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CAFE Study - Cancer Patient Fracture Evaluation

Sponsor
Medtronic Spine LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00211237
Collaborator
(none)
134
Enrollment
20
Locations
2
Arms
55
Duration (Months)
6.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.

Condition or Disease Intervention/Treatment Phase
  • Device: Balloon Kyphoplasty
  • Other: Non Surgical Management
 N/A

Detailed Description

  1. STUDY OBJECTIVES AND ENDPOINTS

1.1. Objectives

The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.

1.2. Primary Endpoint

The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.

1.3. Secondary Endpoints

The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.

Safety:

  • Rate of study treatment-related adverse events

  • Change in neurological status

Clinical:

  • Change in functional status as assessed with Karnofsky Performance Scale

  • Change in quality of life as assessed by the SF-36v2™ Health Survey

  • Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)

  • Change in back-pain analgesics used

  • Change in ambulation status

  • Changes in activities of daily living

  • Time to treatment failure

Radiographic:

  • Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory

  • Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab

In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.

Study Design

Study Type:
Interventional
Actual Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients
Study Start Date :
May 1, 2005
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Balloon Kyphoplasty (BKP)

The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.

Device: Balloon Kyphoplasty
Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
Other Names:
  • KyphX Inflatable Bone Tamps

    		•
    Active Comparator: Non Surgical Management

    The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.

    Other: Non Surgical Management
    Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.

    Outcome Measures

    Primary Outcome Measures

    1. The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month [Baseline and 1 Month]

      The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)

    Secondary Outcome Measures

    1. Change in Roland-Morris Disability Questionnaire Score [Baseline, 1 month, 3 months, 6 months, and 12 months]

      Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).

    2. Change in Functional Status Assessed With the Karnofsky Performance Scale [Baseline and 1 month]

      The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).

    3. Change in Functional Status Assessed With the Karnofsky Performance Scale [Baseline, 1 month, 3 months, 6 months, and 12 months]

      The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).

    4. Change in Back Pain [Baseline and 1 month]

      Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).

    5. Change in Back Pain [Baseline, 1 month, 3 months, 6 months, and 12 months]

      Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).

    6. Change in Quality of Life. [Baseline and 1 month]

      The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.

    7. Change in Quality of Life [Baseline, 1 month, 3 months, 6 months, and 12 months]

      The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.

    8. Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks [Baseline and 1 month]

      The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

    9. Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks [Baseline, 1 month, 3 months, 6 months, and 12 months]

      The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

    10. Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks [Baseline and 1 month]

      The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

    11. Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks [Baseline, 1 month, 3 months, 6 months, and 12 months]

      The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

    12. Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks [Baseline and 1 month]

      The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

    13. Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks [Baseline, 1 month, 3 months, 6 months, and 12 months]

      The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.

    14. Ambulatory Status Change From Baseline to One Month [1 month]

      Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.

    15. Ambulatory Status Change [Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months]

      Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.

    16. Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month [Baseline and 1 month]

      Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.

    17. Index Spinal Deformity Change Measured by Index Vertebral Body Angles [Baseline, post-operation, 1 month, and 12 months]

      Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.

    18. Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio [Baseline and 1 month]

      Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.

    19. Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio [Baseline, post-operation, 1 month, and 12 months]

      Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.

    20. Back Pain Analgesics Used [Baseline, 7 days, and 1 month]

    21. Back Pain Analgesics Used [Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months]

    22. Change in Neurology Status From Baseline (Motor Strength) [1 month]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5

    23. Change in Neurology Status From Baseline (Motor Strength)-Per Protocol [1 month, 3 months, 6 months, and 12 months]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5

    24. Change in Neurological Status From Baseline (Sensory Examination) [1 month]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.

    25. Change in Neurological Status From Baseline (Sensory Examination) [1 months, 3 months, 6 months, and 12 months]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.

    26. Change in Neurological Status From Baseline (Reflex Strength) [1 month]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3

    27. Change in Neurological Status From Baseline (Reflex Strength) [1 months, 3 months, 6 months, and 12 months]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3

    28. Change in Neurological Status From Baseline (Limb Strength) [1 month]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).

    29. Change in Neurological Status From Baseline (Limb Strength) [1 months, 3 months, 6 months, and 12 months]

      The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).

    30. Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline [1 month]

      The study treatment-related AEs were defined as follows: Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.

    31. Rate of Study Treatment-related Adverse Events Till Study Completion [12 months]

      The study treatment-related AEs were defined as follows: Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.

    32. Rate of Subsequent Vertebral Body Fractures [1 month]

    33. Rate of Subsequent Vertebral Body Fractures [1 month and 12 months]

      Based on patients with at least 7 analyzable vertebrae.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s), T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a fracture imaged by plain radiographs using the method of Genant

    2. Pain NRS score ≥4 on a scale of 0 to 10

    • When the patient is newly diagnosed with multiple myeloma, the pain assessment must not be done until after completion of at least one pulse of steroid therapy or one week after the initiation of active multiple myeloma therapy.

    1. Roland Morris Disability Questionnaire score ≥ 10 on a scale of 0 to 24

    2. Patients must be at least 21 years old.

    3. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to enrollment

    4. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1 month following enrollment

    5. No major surgery to the spine planned for at least 1 month following enrollment

    6. Life expectancy of ≥ 3 months

    7. Patient has sufficient mental capacity to comply with the protocol requirements

    8. Patient has stated availability for all study visits

    9. Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.

    Exclusion Criteria:

    1. Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.

    2. Concurrent Phase I investigational anti-cancer treatment

    3. Significant clinical morbidities (aside from the index fracture(s) and cancer) that may potentially interfere with the collection of data concerning pain and function

    4. VCF morphology deemed unsuitable for balloon kyphoplasty

    5. Additional non-kyphoplasty surgical treatment is required for the index fracture

    6. Patients requiring the use of high-dose steroid (≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.

    7. Patients with a platelet count of < 20,000 measured at the time of hospital admission for the procedure

    8. Spinal cord compression or canal compromise requiring decompression

    9. Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors outside of vertebral levels intended for kyphoplasty may be enrolled.

    10. Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)

    11. Known allergy to bone cement or contrast medium used in the treatment of study subjects

    12. MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)

    13. Positive baseline pregnancy test (for women of child-bearing potential)

    14. Patients who may require allogeneic bone marrow transplantation during the course of the study.

    Other Reasons for Lack of Enrollment:

    1. Patient is afraid to have surgery

    2. Patient is afraid to have anesthesia

    3. Patient/family is not willing to participate in research

    4. Patient is not willing to be randomized

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Valley Radiology Inc., UCSD Escondido California United States 92025
    2 Boulder Neurosurgical Associates Boulder Colorado United States 80304
    3 H. Lee Moffitt Cancer Center Tampa Florida United States 33612
    4 Sibley Memorial Hospital Chevy Chase Maryland United States 20815
    5 Greater Oncology Associates Silver Spring Maryland United States 20910
    6 Karmanos Cancer Center Detroit Michigan United States 48201
    7 Cleveland Clinic Cleveland Ohio United States 44195
    8 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    9 University of Utah Salt Lake City Utah United States 84132
    10 St. Vincent's Hospital Fitzroy Victoria Australia 3065
    11 The Alfred Hospital Melbourne Victoria Australia 3004
    12 Institut Jules Bordet Brussels Belgium
    13 Foothills Hospital Calgary Alberta Canada T2N2T9
    14 Toronto Western Hospital Toronto Ontario Canada M5T 2S8
    15 Montreal General Hospital Montreal Quebec Canada H3G 1A4
    16 Charité Virchow-Klinikum Berlin Germany
    17 Medizinische Hochschule Hannover Germany
    18 National Center for Spinal Disorders Budapest Hungary
    19 Akademiska Sjukhuset Uppsala Sweden
    20 Royal London London United Kingdom

    Sponsors and Collaborators

    • Medtronic Spine LLC

    Investigators

    • Principal Investigator: James Berenson, M.D., Institute for Myeloma & Bone Cancer Research
    • Principal Investigator: Frank Vrionis, M.D., H. Lee Moffitt Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Spine LLC
    ClinicalTrials.gov Identifier:
    NCT00211237
    Other Study ID Numbers:
    • SP0401 - CAFE Study
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Jun 1, 2017
    Keywords provided by Medtronic Spine LLC
    Balloon Kyphoplasty
    Cancer
    Vertebral Compression Fracture
    Back Pain
    Spine
    Additional relevant MeSH terms:
    Fractures, Bone
    Spinal Fractures

    Study Results

    Participant Flow

    Recruitment Details Of 134 enrolled subjects, 70 were randomized to Balloon Kyphoplasty and 64 to non-surgical management (NSM). Two of the subjects who were randomized to Balloon Kyphoplasty and 3 of the subjects who were randomized to NSM were excluded from the mITT and PP Populations, because they terminated in a few days of enrolment and had no treatment.
    Pre-assignment Detail Crossover from the NSM group to Balloon Kyphoplasty group was permitted after completion of the 1-month evaluation.
    Arm/Group Title Balloon Kyphoplasty Non-surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Period Title: Baseline
    STARTED 70 64 0
    COMPLETED 68 61 0
    NOT COMPLETED 2 3 0
    Period Title: Baseline
    STARTED 68 61 0
    COMPLETED 65 52 0
    NOT COMPLETED 3 9 0
    Period Title: Baseline
    STARTED 65 18 34
    COMPLETED 57 14 33
    NOT COMPLETED 8 4 1
    Period Title: Baseline
    STARTED 57 11 36
    COMPLETED 49 9 33
    NOT COMPLETED 8 2 3
    Period Title: Baseline
    STARTED 49 8 34
    COMPLETED 40 6 28
    NOT COMPLETED 9 2 6

    Baseline Characteristics

    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Total
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Total of all reporting groups
    Overall Participants 70 64 134
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.8
    (10.8)
    63.0
    (11.4)
    63.9
    (11.0)
    Sex/Gender, Customized (participants) [Number]
    Male
    28
    40%
    26
    40.6%
    54
    40.3%
    Female
    40
    57.1%
    35
    54.7%
    75
    56%
    Missing
    2
    2.9%
    3
    4.7%
    5
    3.7%

    Outcome Measures

    1. Primary Outcome
    Title The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month
    Description The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability)
    Time Frame Baseline and 1 Month

    Outcome Measure Data

    Analysis Population Description
    The analyses of change from Baseline included only patients in the modified Intent-to-Treat (mITT) population who provided evaluable data at both Baseline and at 1 month after receipt of the initially assigned study treatment.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group received the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group received the non-operative treatments that aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 63 50
    Baseline
    17.6
    18.2
    One month
    9.1
    18.0
    Change from baseline to one month
    -8.3
    0.1
    2. Secondary Outcome
    Title Change in Roland-Morris Disability Questionnaire Score
    Description Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non-Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    RMDQ score at baseline
    17.6
    (3.9)
    17.9
    (4.2)
    18.3
    (2.6)
    Change from baseline to 1 months
    -8.3
    (7.6)
    0.3
    (3.1)
    -7.3
    (6.8)
    Change from baseline to 3 months
    -8.9
    (7.0)
    -2.7
    (6.1)
    -10.2
    (6.1)
    Change from baseline to 6 months
    -8.2
    (6.0)
    -3.6
    (9.4)
    -10.8
    (6.1)
    Change from baseline to 12 months
    -9.7
    (6.4)
    -4.5
    (11.4)
    -10.4
    (6.0)
    3. Secondary Outcome
    Title Change in Functional Status Assessed With the Karnofsky Performance Scale
    Description The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Baseline score
    57.1
    (18.0)
    57.3
    (15.8)
    Score at 1 month
    73.2
    (15.5)
    58.6
    (16.2)
    Change from baseline to one month
    15.9
    (21.2)
    0.6
    (11.6)
    4. Secondary Outcome
    Title Change in Functional Status Assessed With the Karnofsky Performance Scale
    Description The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Baseline score
    57.1
    (18.0)
    55.0
    (17.7)
    58.7
    (14.6)
    Change from baseline to 1 month
    15.9
    (21.2)
    0.0
    (14.1)
    19.2
    (20.6)
    Change from baseline to 3 months
    18.0
    (23.8)
    10.0
    (16.3)
    21.1
    (19.1)
    Change from baseline to 6 months
    18.0
    (23.1)
    12.5
    (21.2)
    23.3
    (19.8)
    Change from baseline to 12 months
    23.0
    (25.2)
    21.7
    (23.2)
    22.2
    (18.0)
    5. Secondary Outcome
    Title Change in Back Pain
    Description Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Baseline
    7.3
    (1.6)
    7.3
    (1.4)
    1 month
    3.3
    (2.8)
    6.9
    (1.5)
    Change from baseline to 1 month
    -3.9
    (3.2)
    -0.6
    (1.8)
    6. Secondary Outcome
    Title Change in Back Pain
    Description Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Back pain at baseline
    7.3
    (1.6)
    6.8
    (1.5)
    7.6
    (1.4)
    Change from baseline to 7 days
    -3.8
    (3.0)
    -0.7
    (1.8)
    -4.0
    (3.1)
    Change from baseline to 1 month
    -3.9
    (3.2)
    -0.9
    (2.0)
    -4.1
    (2.9)
    Change from baseline to 3 months
    -3.6
    (3.3)
    -2.1
    (2.1)
    -4.3
    (2.8)
    Change from baseline to 6 months
    -3.7
    (3.2)
    -2.4
    (3.9)
    -4.8
    (2.9)
    Change from baseline to 12 months
    -3.9
    (3.2)
    -3.0
    (3.2)
    -4.9
    (3.0)
    7. Secondary Outcome
    Title Change in Quality of Life.
    Description The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    SF-36 PCS at baseline
    25.4
    (6.0)
    24.8
    (6.4)
    SF-36 PCS at 1 month
    35.2
    (10.1)
    26.0
    (6.3)
    PCS change from baseline to 1 month
    9.4
    (9.4)
    1.0
    (6.0)
    SF-36 MCS at baseline
    38.2
    (13.3)
    37.3
    (13.4)
    SF-36 MCS at 1 month
    46.4
    (13.0)
    36.1
    (13.6)
    MCS change from baseline to 1 month
    9.2
    (14.6)
    -1.9
    (12.7)
    8. Secondary Outcome
    Title Change in Quality of Life
    Description The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    SF-36 PCS at baseline
    25.4
    (6.0)
    25.3
    (4.8)
    24.5
    (7.2)
    PCS change from baseline to 1 months
    9.4
    (9.4)
    -0.2
    (4.2)
    9.1
    (9.5)
    PCS change from baseline to 3 months
    10.0
    (11.1)
    1.1
    (6.4)
    11.1
    (9.3)
    PCS change from baseline to 6 months
    9.1
    (9.1)
    -0.8
    (6.2)
    10.8
    (9.2)
    PCS change from baseline to 12 months
    11.7
    (10.3)
    1.3
    (9.1)
    11.9
    (7.9)
    SF-36 MCS at baseline
    38.2
    (13.3)
    36.0
    (14.7)
    38.1
    (12.7)
    MCS change from baseline to 1 month
    9.2
    (14.6)
    -1.1
    (12.4)
    6.8
    (15.9)
    MCS change from baseline to 3 months
    7.6
    (15.0)
    7.3
    (13.4)
    9.2
    (17.0)
    MCS change from baseline to 6 months
    8.5
    (15.2)
    4.3
    (12.1)
    13.1
    (15.5)
    MCS change from baseline to 12 months
    7.8
    (15.5)
    5.6
    (12.5)
    9.2
    (17.1)
    9. Secondary Outcome
    Title Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
    Description The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Activities reduced at baseline
    90
    128.6%
    97
    151.6%
    No activities reduced at baseline
    8.8
    12.6%
    1.6
    2.5%
    Don't known at baseline
    1.5
    2.1%
    0
    0%
    Activities reduced at 1 month
    56
    80%
    75
    117.2%
    No activities reduced at 1 month
    38
    54.3%
    6.6
    10.3%
    Don't know at 1 month
    0
    0%
    0
    0%
    10. Secondary Outcome
    Title Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks
    Description The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Activities reduced at baseline
    90
    128.6%
    96
    150%
    97
    72.4%
    No activities reduced at baseline
    8.8
    12.6%
    4.3
    6.7%
    2.6
    1.9%
    Don't known at baseline
    1.5
    2.1%
    0
    0%
    0.0
    0%
    Activities reduced at 1 month
    56
    80%
    48
    75%
    53
    39.6%
    No activities reduced at 1 month
    38
    54.3%
    4.3
    6.7%
    47
    35.1%
    Don't know at 1 month
    0
    0%
    0
    0%
    0
    0%
    Activities reduced at 3 months
    37
    52.9%
    39
    60.9%
    34
    25.4%
    No activities reduced at 3 months
    43
    61.4%
    4.3
    6.7%
    58
    43.3%
    Don't know at 3 months
    0
    0%
    0.0
    0%
    2.6
    1.9%
    Activities reduced at 6 months
    34
    48.6%
    26
    40.6%
    32
    23.9%
    No activities reduced at 6 months
    38
    54.3%
    8.7
    13.6%
    55
    41%
    Don't know at 6 months
    0
    0%
    0
    0%
    0
    0%
    Activities reduced at 12 months
    19
    27.1%
    17
    26.6%
    39
    29.1%
    No activities reduced at 12 months
    40
    57.1%
    8.7
    13.6%
    32
    23.9%
    Don't know at 12 months
    0
    0%
    0
    0%
    0
    0%
    11. Secondary Outcome
    Title Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
    Description The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Baseline
    10.8
    (4.9)
    11.5
    (4.3)
    Change from baseline to one month
    -5.2
    (7.1)
    1.1
    (4.5)
    12. Secondary Outcome
    Title Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks
    Description The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Baseline
    10.8
    (4.9)
    12.0
    (3.6)
    11.0
    (4.8)
    Change from baseline to 1 months
    -5.2
    (7.1)
    -0.4
    (3.3)
    -5.6
    (7.2)
    Change from baseline to 3 months
    -5.5
    (7.0)
    -1.8
    (6.3)
    -7.4
    (7.1)
    Change from baseline to 6 months
    -5.0
    (7.9)
    -2.9
    (7.9)
    -8.5
    (5.2)
    Change from baseline to 12 months
    -7.8
    (6.4)
    -5.2
    (5.2)
    -7.4
    (7.3)
    13. Secondary Outcome
    Title Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
    Description The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Baseline
    6.3
    (6.3)
    6.8
    (6.0)
    Change from baseline to 1 month
    -4.0
    (7.7)
    0.2
    (4.7)
    14. Secondary Outcome
    Title Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks
    Description The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
    Time Frame Baseline, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Baseline
    6.3
    (6.3)
    8.1
    (5.9)
    5.8
    (6.0)
    Change from baseline to 1 month
    -4.0
    (7.7)
    -0.2
    (5.9)
    -4.5
    (6.0)
    Change from baseline to 3 months
    -3.4
    (7.7)
    -4.8
    (6.0)
    -5.0
    (6.1)
    Change from baseline to 6 months
    -3.8
    (7.6)
    -4.1
    (7.8)
    -5.7
    (5.9)
    Change from baseline to 12 months
    -5.8
    (6.3)
    -4.3
    (6.2)
    -4.7
    (6.8)
    15. Secondary Outcome
    Title Ambulatory Status Change From Baseline to One Month
    Description Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Fully ambulatory at baseline
    56
    80%
    56
    87.5%
    Assisted ambulatory
    32
    45.7%
    34
    53.1%
    Not ambulatory
    10
    14.3%
    8.2
    12.8%
    Ambulatory status improved at 1 month
    16
    22.9%
    6.6
    10.3%
    No change in ambulatory status at 1 month
    74
    105.7%
    66
    103.1%
    Ambulatory status worsened at 1 month
    2.9
    4.1%
    9.8
    15.3%
    16. Secondary Outcome
    Title Ambulatory Status Change
    Description Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
    Time Frame Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Full ambulatory at baseline
    56
    80%
    57
    89.1%
    55
    41%
    Assisted ambulatory at baseline
    32
    45.7%
    30
    46.9%
    39
    29.1%
    Not ambulatory at baseline
    10
    14.3%
    13
    20.3%
    5.3
    4%
    Ambulatory status improved at 7 days
    10
    14.3%
    0
    0%
    7.9
    5.9%
    Ambulatory status no change at 7 days
    79
    112.9%
    70
    109.4%
    87
    64.9%
    Ambulatory status worsened at 7 days
    2.9
    4.1%
    0
    0%
    5.3
    4%
    Ambulatory status improved at 1 month
    16
    22.9%
    0
    0%
    11
    8.2%
    Ambulatory status no change at 1 month
    74
    105.7%
    39
    60.9%
    87
    64.9%
    Ambulatory status worsened at 1 month
    2.9
    4.1%
    13
    20.3%
    2.6
    1.9%
    Ambulatory status improved at 3 months
    18
    25.7%
    4.3
    6.7%
    16
    11.9%
    Ambulatory status no change at 3 months
    53
    75.7%
    35
    54.7%
    76
    56.7%
    Ambulatory status worsened at 3 months
    8.8
    12.6%
    4.3
    6.7%
    2.6
    1.9%
    Ambulatory status improved at 6 months
    10
    14.3%
    4.3
    6.7%
    16
    11.9%
    Ambulatory status no change at 6 months
    54
    77.1%
    26
    40.6%
    63
    47%
    Ambulatory status worsened at 6 months
    5.9
    8.4%
    4.3
    6.7%
    7.9
    5.9%
    Ambulatory status improved at 12 months
    12
    17.1%
    4.3
    6.7%
    16
    11.9%
    Ambulatory status no change at 12 months
    41
    58.6%
    17
    26.6%
    53
    39.6%
    Ambulatory status worsened at 12 months
    4.4
    6.3%
    4.3
    6.7%
    2.6
    1.9%
    17. Secondary Outcome
    Title Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month
    Description Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Kyphotic angle at baseline
    9.523
    (8.751)
    10.501
    (8.833)
    Kyphotic angle change at 1 month
    0.135
    (5.088)
    -0.598
    (3.442)
    Thoracic cobb angle at baseline
    50.976
    (17.316)
    51.390
    (19.621)
    Thoracic cobb angle change to one month
    0.666
    (9.253)
    -0.012
    (8.150)
    Lumbar cobb angle at baseline
    -32.335
    (16.410)
    -33.101
    (15.179)
    Lumbar cobb angle change at 1 month
    0.626
    (7.075)
    2.883
    (7.634)
    Local Cobb angel of T5-L1 at baseline
    22.914
    (12.720)
    22.792
    (15.191)
    Local cobb angle of T5-L1 change at 1 month
    1.126
    (5.639)
    1.608
    (5.631)
    Local cobb angle of L2-L4 at baseline
    -7.715
    (15.470)
    -8.291
    (14.662)
    Local cobb angle of L2-L4 change at 1 month
    0.117
    (5.694)
    -1.149
    (5.576)
    18. Secondary Outcome
    Title Index Spinal Deformity Change Measured by Index Vertebral Body Angles
    Description Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
    Time Frame Baseline, post-operation, 1 month, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Kyphotic angle at baseline
    9.523
    (8.751)
    10.806
    (8.962)
    11.005
    (8.798)
    Kyphotic angle change at post-operation
    1.312
    (4.909)
    NA
    (NA)
    1.438
    (4.191)
    Kyphotic angle change at 1 month
    0.135
    (5.088)
    -0.130
    (4.203)
    0.637
    (4.545)
    Kyphotic angle change at 12 month
    0.954
    (5.626)
    -1.246
    (3.404)
    0.824
    (4.425)
    Thoracic cobb angle at baseline
    50.976
    (17.316)
    53.148
    (15.837)
    52.812
    (19.671)
    Thoracic cobb angle change at post-op
    -1.804
    (9.701)
    NA
    (NA)
    -2.489
    (4.823)
    Thoracic cobb angle change at 1 month
    0.666
    (9.253)
    -1.633
    (8.212)
    -0.457
    (5.682)
    Thoracic cobb angle change at 12 months
    0.988
    (8.947)
    0.062
    (7.332)
    -1.372
    (6.187)
    Lumbar cobb angle at baseline
    -32.335
    (16.410)
    -31.218
    (12.656)
    -32.906
    (15.718)
    Lumbar cobb angle change at post-op
    -0.472
    (5.617)
    NA
    (NA)
    -1.396
    (4.575)
    Lumbar cobb angle change at 1 month
    0.626
    (7.075)
    5.661
    (10.117)
    0.839
    (5.336)
    Lumbar cobb angle change at 12 months
    1.232
    (7.785)
    -1.412
    (3.634)
    2.057
    (13.535)
    Local cobb angle of T5-L1 at baseline
    22.914
    (12.720)
    23.519
    (11.363)
    23.847
    (15.945)
    Local cobb angle of T5-L1 change at post-op
    -0.506
    (4.231)
    NA
    (NA)
    -2.080
    (5.311)
    Local cobb angle of T5-L1 change at 1 month
    1.126
    (5.639)
    0.357
    (7.731)
    -0.746
    (5.230)
    Local cobb angle of T5-L1 change at 12 months
    1.550
    (5.525)
    1.638
    (1.998)
    -1.333
    (4.781)
    Local cobb angle of L2-L4 at baseline
    -7.715
    (15.470)
    -6.581
    (9.957)
    -6.945
    (14.496)
    Local cobb angle of L2-L4 change at post-op
    -1.834
    (7.886)
    NA
    (NA)
    -0.610
    (4.094)
    Local cobb angle of L2-L4 change at 1 month
    0.117
    (5.694)
    -0.105
    (5.106)
    -0.770
    (3.376)
    Local cobb angle of L2-L4 change at 12 months
    0.005
    (4.925)
    -0.346
    (3.197)
    -1.157
    (3.604)
    19. Secondary Outcome
    Title Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
    Description Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
    Time Frame Baseline and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Anterior VBHR at baseline
    0.744
    (0.228)
    0.734
    (0.237)
    Anterior VBHR change at 1 month
    0.016
    (0.123)
    -0.027
    (0.061)
    Medial VBHR at baseline
    0.782
    (0.193)
    0.776
    (0.190)
    Medial VBHR change at 1 month
    0.028
    (0.103)
    -0.017
    (0.068)
    Posterior VBHR at baseline
    0.928
    (0.101)
    0.934
    (0.110)
    Posterior change at 1 month
    0.007
    (0.081)
    -0.012
    (0.058)
    20. Secondary Outcome
    Title Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
    Description Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
    Time Frame Baseline, post-operation, 1 month, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Anterior VBHR at baseline
    0.744
    (0.228)
    0.767
    (0.254)
    0.741
    (0.224)
    Anterior VBHR change at post-op
    0.060
    (0.117)
    NA
    (NA)
    0.024
    (0.084)
    Anterior VBHR change at 1 month
    0.016
    (0.123)
    -0.036
    (0.054)
    0.006
    (0.065)
    Anterior VBHR change at 12 months
    0.022
    (0.129)
    -0.022
    (0.072)
    0.039
    (0.145)
    Medial VBHR at baseline
    0.782
    (0.193)
    0.741
    (0.239)
    0.800
    (0.176)
    Medial VBHR change at post-op
    0.044
    (0.099)
    NA
    (NA)
    0.019
    (0.075)
    Medial VBHR change at 1 month
    0.028
    (0.103)
    -0.031
    (0.074)
    0.012
    (0.071)
    Medial VBHR change at 12 months
    0.018
    (0.110)
    0.021
    (0.117)
    0.049
    (0.087)
    Posterior VBHR at baseline
    0.928
    (0.101)
    0.899
    (0.166)
    0.951
    (0.110)
    Posterior VBHR change at post-op
    0.007
    (0.064)
    NA
    (NA)
    -0.006
    (0.059)
    Posterior VBHR change at 1 month
    0.007
    (0.081)
    -0.022
    (0.045)
    0.016
    (0.069)
    Posterior VBHR change at 12 months
    -0.001
    (0.077)
    -0.026
    (0.049)
    0.006
    (0.053)
    21. Secondary Outcome
    Title Back Pain Analgesics Used
    Description
    Time Frame Baseline, 7 days, and 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Back pain analgesic use at baseline
    96
    137.1%
    84
    131.3%
    Back pain analgesic use at 7 days
    82
    117.1%
    80
    125%
    Back pain analgesic use at 1 month
    60
    85.7%
    72
    112.5%
    22. Secondary Outcome
    Title Back Pain Analgesics Used
    Description
    Time Frame Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Back pain analgesic use at baseline
    96
    137.1%
    78
    121.9%
    87
    64.9%
    Back pain analgesic use at 7 days
    82
    117.1%
    61
    95.3%
    68
    50.7%
    Back pain analgesic use at 1 month
    60
    85.7%
    39
    60.9%
    66
    49.3%
    Back pain analgesic use at 3 months
    43
    61.4%
    30
    46.9%
    58
    43.3%
    Back pain analgesic use at 6 months
    40
    57.1%
    22
    34.4%
    39
    29.1%
    Back pain analgesic use at 12 months
    19
    27.1%
    13
    20.3%
    26
    19.4%
    23. Secondary Outcome
    Title Change in Neurology Status From Baseline (Motor Strength)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Improved at 1 month
    8.8
    12.6%
    3.3
    5.2%
    Unchanged at 1 month
    84
    120%
    74
    115.6%
    Worsened at 1 month
    1.5
    2.1%
    3.3
    5.2%
    24. Secondary Outcome
    Title Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following: absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
    Time Frame 1 month, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Improved at 1 month
    8.8
    12.6%
    8.7
    13.6%
    2.6
    1.9%
    Unchanged at 1 month
    84
    120%
    39
    60.9%
    92
    68.7%
    Worsened at in month
    1.5
    2.1%
    4.3
    6.7%
    2.6
    1.9%
    Improved at 3 months
    7.4
    10.6%
    4.3
    6.7%
    7.9
    5.9%
    Unchanged at 3 months
    68
    97.1%
    35
    54.7%
    84
    62.7%
    Worsened at 3 months
    2.9
    4.1%
    4.3
    6.7%
    2.6
    1.9%
    Improved at 6 months
    5.9
    8.4%
    4.3
    6.7%
    11
    8.2%
    Unchanged at 6 months
    62
    88.6%
    30
    46.9%
    68
    50.7%
    Worsened at 6 months
    4.4
    6.3%
    0.0
    0%
    7.9
    5.9%
    Improved at 12 months
    2.9
    4.1%
    4.3
    6.7%
    5.3
    4%
    Unchanged at 12 months
    53
    75.7%
    22
    34.4%
    66
    49.3%
    Worsened at 12 months
    2.9
    4.1%
    0.0
    0%
    0.0
    0%
    25. Secondary Outcome
    Title Change in Neurological Status From Baseline (Sensory Examination)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Improved
    2.9
    4.1%
    1.6
    2.5%
    Unchanged
    91
    130%
    79
    123.4%
    Worsened
    0.0
    0%
    0.0
    0%
    26. Secondary Outcome
    Title Change in Neurological Status From Baseline (Sensory Examination)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
    Time Frame 1 months, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Improved at 1 month
    2.9
    4.1%
    0.0
    0%
    2.6
    1.9%
    Unchanged at 1 month
    91
    130%
    52
    81.3%
    95
    70.9%
    Worsened at 1 month
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Improved at 3 months
    1.5
    2.1%
    0.0
    0%
    2.6
    1.9%
    Unchanged at 3 months
    78
    111.4%
    43
    67.2%
    92
    68.7%
    Worsened at 3 months
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Improved at 6 months
    0.0
    0%
    0.0
    0%
    2.6
    1.9%
    Unchanged at 6 months
    71
    101.4%
    35
    54.7%
    84
    62.7%
    Worsened at 6 months
    1.5
    2.1%
    0.0
    0%
    0.0
    0%
    Improved at 12 months
    1.5
    2.1%
    4.3
    6.7%
    0.0
    0%
    Unchanged at 12 months
    57
    81.4%
    22
    34.4%
    66
    49.3%
    Worsened at 12 months
    0.0
    0%
    0.0
    0%
    5.3
    4%
    27. Secondary Outcome
    Title Change in Neurological Status From Baseline (Reflex Strength)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Improved
    7.4
    10.6%
    8.2
    12.8%
    Unchanged
    85
    121.4%
    69
    107.8%
    Worsened
    1.5
    2.1%
    3.3
    5.2%
    28. Secondary Outcome
    Title Change in Neurological Status From Baseline (Reflex Strength)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following: absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
    Time Frame 1 months, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Improved at 1 month
    7.4
    10.6%
    4.3
    6.7%
    5.3
    4%
    Unchanged at 1 month
    85
    121.4%
    43
    67.2%
    82
    61.2%
    Worsened at 1 month
    1.5
    2.1%
    4.3
    6.7%
    11.0
    8.2%
    Improved at 3 months
    2.9
    4.1%
    4.3
    6.7%
    2.6
    1.9%
    Unchanged at 3 months
    74
    105.7%
    39
    60.9%
    82
    61.2%
    Worsened at 3 months
    2.9
    4.1%
    0.0
    0%
    11.0
    8.2%
    Improved at 6 months
    5.9
    8.4%
    0.0
    0%
    7.9
    5.9%
    Unchanged at 6 months
    65
    92.9%
    35
    54.7%
    71
    53%
    Worsened at 6 months
    1.5
    2.1%
    0.0
    0%
    7.9
    5.9%
    Improved at 12 months
    2.9
    4.1%
    0.0
    0%
    7.9
    5.9%
    Unchanged at 12 months
    53
    75.7%
    26
    40.6%
    63
    47%
    Worsened at 12 months
    2.9
    4.1%
    0.0
    0%
    0.0
    0%
    29. Secondary Outcome
    Title Change in Neurological Status From Baseline (Limb Strength)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 68 61
    Improved
    12
    17.1%
    4.9
    7.7%
    Unchanged
    81
    115.7%
    67
    104.7%
    Worsened
    1.5
    2.1%
    8.2
    12.8%
    30. Secondary Outcome
    Title Change in Neurological Status From Baseline (Limb Strength)
    Description The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
    Time Frame 1 months, 3 months, 6 months, and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    Improved at 1 month
    12
    17.1%
    0.0
    0%
    16
    11.9%
    Unchanged at 1 month
    81
    115.7%
    48
    75%
    82
    61.2%
    Worsened at 1 month
    1.5
    2.1%
    4.3
    6.7%
    0.0
    0%
    Improved at 3 months
    4.4
    6.3%
    0.0
    0%
    13
    9.7%
    Unchanged at 3 months
    71
    101.4%
    39
    60.9%
    79
    59%
    Worsened at 3 months
    4.4
    6.3%
    4.3
    6.7%
    2.6
    1.9%
    Improved at 6 months
    7.4
    10.6%
    0.0
    0%
    13
    9.7%
    Unchanged at 6 months
    63
    90%
    30
    46.9%
    71
    53%
    Worsened at 6 months
    1.5
    2.1%
    4.3
    6.7%
    2.6
    1.9%
    Improved at 12 months
    4.4
    6.3%
    4.3
    6.7%
    11
    8.2%
    Unchanged at 12 months
    51
    72.9%
    22
    34.4%
    58
    43.3%
    Worsened at 12 months
    2.9
    4.1%
    0.0
    0%
    2.6
    1.9%
    31. Secondary Outcome
    Title Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline
    Description The study treatment-related AEs were defined as follows: Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    All of the randomized subjects were included in safety population analysis.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects were randomized to the Balloon Kyphoplasty. The subjects were randomized to NSM.
    Measure Participants 70 64
    Unrelated
    33
    47.1%
    30
    46.9%
    Possibly related
    1.4
    2%
    0
    0%
    Related
    4.3
    6.1%
    0
    0%
    Unknown
    2.9
    4.1%
    0
    0%
    32. Secondary Outcome
    Title Rate of Study Treatment-related Adverse Events Till Study Completion
    Description The study treatment-related AEs were defined as follows: Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient. Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated. Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device. Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    All of randomized subjects were included in safety population analysis.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover (AEs Collected Before BKP) Crossover-(AEs Collected After BKP)
    Arm/Group Description The subjects were randomized to Balloon Kyphoplasty. The subjects were randomized to NSM without crossing over. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 70 26 38 38
    Unrelated
    77
    110%
    50
    78.1%
    37
    27.6%
    79
    NaN
    Possibly related
    1.4
    2%
    0
    0%
    0
    0%
    2.6
    NaN
    Related
    4.3
    6.1%
    0
    0%
    0
    0%
    2.6
    NaN
    Unknown
    10
    14.3%
    0
    0%
    0
    0%
    7.9
    NaN
    33. Secondary Outcome
    Title Rate of Subsequent Vertebral Body Fractures
    Description
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    Subjects were analyzed in modified Intent-to-Treat (mITT) population, based on their randomized treatment group (regardless of crossover). This analysis included all subjects in the mITT population who provided evaluable data at both baseline and 1 month.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    Measure Participants 62 47
    Number [percentage of participants]
    19.6
    28%
    17.0
    26.6%
    34. Secondary Outcome
    Title Rate of Subsequent Vertebral Body Fractures
    Description Based on patients with at least 7 analyzable vertebrae.
    Time Frame 1 month and 12 months

    Outcome Measure Data

    Analysis Population Description
    The analysis population was per-protocol analysis, which was based on the treatment that subjects received. Of 61 subjects randomized into NSM group, 38 subjects crossed over from NSM to Kyphoplasty after the 1-month visit, and 23 subjects remained in NSM group.
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management Crossover
    Arm/Group Description The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs. The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs. Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.
    Measure Participants 68 23 38
    1 month
    19.4
    27.7%
    23.1
    36.1%
    11.8
    8.8%
    12 months
    13.2
    18.9%
    0.0
    0%
    7.4
    5.5%

    Adverse Events

    Time Frame Adverse Events within 30 Days of treatment
    Adverse Event Reporting Description
    Arm/Group Title Balloon Kyphoplasty Non Surgical Management
    Arm/Group Description The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs. The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
    All Cause Mortality
    Balloon Kyphoplasty Non Surgical Management
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Balloon Kyphoplasty Non Surgical Management
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/70 (21.4%) 11/64 (17.2%)
    Cardiac disorders
    Arrhythmia 2/70 (2.9%) 2 1/64 (1.6%) 1
    Cardiac failure congestive 0/70 (0%) 0 1/64 (1.6%) 1
    Myocardial infarction 1/70 (1.4%) 1 0/64 (0%) 0
    Gastrointestinal disorders
    Gastric hypomotility 1/70 (1.4%) 1 0/64 (0%) 0
    General disorders
    Asthenia 1/70 (1.4%) 1 0/64 (0%) 0
    General Physical Health Deterioration 1/70 (1.4%) 1 1/64 (1.6%) 1
    Malaise 0/70 (0%) 0 1/64 (1.6%) 1
    Pyrexia 1/70 (1.4%) 1 0/64 (0%) 0
    Infections and infestations
    Pneumonia 0/70 (0%) 0 1/64 (1.6%) 1
    Staphylococcal Infection 1/70 (1.4%) 1 0/64 (0%) 0
    Injury, poisoning and procedural complications
    Post Procedural Myocardial Infarction 1/70 (1.4%) 1 0/64 (0%) 0
    Procedural Pain 1/70 (1.4%) 1 0/64 (0%) 0
    Urinary Retention Postoperative 1/70 (1.4%) 1 0/64 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back Pain 1/70 (1.4%) 1 4/64 (6.3%) 4
    Bone Pain 1/70 (1.4%) 1 0/64 (0%) 0
    Vertebral Fracture 2/70 (2.9%) 4 3/64 (4.7%) 4
    Nervous system disorders
    Paraplegia 0/70 (0%) 0 1/64 (1.6%) 1
    Paresis 1/70 (1.4%) 1 0/64 (0%) 0
    Syncope 0/70 (0%) 0 1/64 (1.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/70 (1.4%) 1 0/64 (0%) 0
    Vascular disorders
    Deep Vein Thrombosis 0/70 (0%) 0 1/64 (1.6%) 1
    Other (Not Including Serious) Adverse Events
    Balloon Kyphoplasty Non Surgical Management
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/70 (22.9%) 11/64 (17.2%)
    Blood and lymphatic system disorders
    Neutropenia 0/70 (0%) 0 1/64 (1.6%) 1
    Cardiac disorders
    Angina Pectoris 0/70 (0%) 0 1/64 (1.6%) 1
    Eye disorders
    Diplopia 0/70 (0%) 0 1/64 (1.6%) 1
    Gastrointestinal disorders
    Diarrhoea 1/70 (1.4%) 1 0/64 (0%) 0
    Diarrhoea Haemorrhagic 0/70 (0%) 0 1/64 (1.6%) 1
    Dyspepsia 1/70 (1.4%) 1 0/64 (0%) 0
    Gastritis 0/70 (0%) 0 1/64 (1.6%) 1
    Ileus 1/70 (1.4%) 1 0/64 (0%) 0
    General disorders
    General Physical Health Deterioration 0/70 (0%) 0 1/64 (1.6%) 1
    Implant Site Extravasation 2/70 (2.9%) 2 0/64 (0%) 0
    Infections and infestations
    Herpes Zoster 0/70 (0%) 0 1/64 (1.6%) 1
    Influenza 1/70 (1.4%) 1 0/64 (0%) 0
    Laryngitis 1/70 (1.4%) 1 0/64 (0%) 0
    Urinary Tract Infection 2/70 (2.9%) 2 1/64 (1.6%) 1
    Wound Infection 1/70 (1.4%) 1 0/64 (0%) 0
    Injury, poisoning and procedural complications
    Device Breakage 1/70 (1.4%) 1 0/64 (0%) 0
    Investigations
    Haemoglobin Decreased 1/70 (1.4%) 1 0/64 (0%) 0
    Metabolism and nutrition disorders
    Decreased Appetite 0/70 (0%) 0 1/64 (1.6%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/70 (1.4%) 1 0/64 (0%) 0
    Back Pain 3/70 (4.3%) 3 1/64 (1.6%) 1
    Bursitis 1/70 (1.4%) 1 0/64 (0%) 0
    Joint Swelling 1/70 (1.4%) 1 0/64 (0%) 0
    Musculoskeletal Chest Pain 1/70 (1.4%) 1 0/64 (0%) 0
    Vertebral Fracture 1/70 (1.4%) 1 0/64 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer 0/70 (0%) 0 1/64 (1.6%) 1
    Nervous system disorders
    Hypoaesthesia 1/70 (1.4%) 1 0/64 (0%) 0
    Psychiatric disorders
    Depression 0/70 (0%) 0 1/64 (1.6%) 1
    Psychotic Disorder 0/70 (0%) 0 1/64 (1.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/70 (0%) 0 1/64 (1.6%) 1
    Cough 1/70 (1.4%) 1 0/64 (0%) 0
    Vascular disorders
    Lymphoedema 0/70 (0%) 0 1/64 (1.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Clinical Department
    Organization Medtronic Spine and Biologics
    Phone 1800-876-3133 ext 6068
    Email msbkclinicalresearch@medtronic.com
    Responsible Party:
    Medtronic Spine LLC
    ClinicalTrials.gov Identifier:
    NCT00211237
    Other Study ID Numbers:
    • SP0401 - CAFE Study
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Jun 1, 2017