Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT01383616
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 77
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.

Condition or Disease	Intervention/Treatment	Phase
Vertebral Compression Fracture	Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Unipedicular kyphoplasty Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.	Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA); A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Active Comparator: Bipedicular Kyphoplasty group Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.	Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA); A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Outcome Measures

Primary Outcome Measures

1. Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups [Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery]

   The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

2. Change in RDQ in the Bipedicular Group From 3 to 12 Months [3-12 months post operation]

   The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.

Secondary Outcome Measures

1. Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty [Preoperative assessment within 3 weeks before surgery and postoperative day 1]

   Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.

2. Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty [Preoperative assessment within 3 weeks before surgery and postoperative day 1]

   Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery

3. Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups [3 months post-op]

   The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.

4. Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups [3 months post-op]

   A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain

5. Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups [12 months post-op]

   Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.[2] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible

6. Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups [12 months post-op]

   The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.

7. Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups [12 months post-op]

   A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain

8. Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty [Preoperative assessment within 3 weeks before surgery and postoperative day 1]

   Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.

Exclusion Criteria:

• primary tumors of bone or evidence of metastasis at the index vertebrae

• pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis

• fracture secondary to a traumatic event

• inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Study Director: Tzipora Kuba, PhD, Hospital for Special Surgery, New York
• Principal Investigator: Joseph M Lane, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT01383616
• Other Study ID Numbers: 26033
• First Posted: Jun 28, 2011
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Hospital for Special Surgery, New York: osteoporosis; vertebral compression fractures
• Additional relevant MeSH terms: Fractures, Bone; Spinal Fractures; Fractures, Compression

Study Results

Participant Flow

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
Period Title: Overall Study
STARTED	40	44
COMPLETED	23	21
NOT COMPLETED	17	23

Baseline Characteristics

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group	Total
Arm/Group Description	In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	Total of all reporting groups
Overall Participants	23	21	44
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	23 100%	21 100%	44 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.7 (7.8)	79.3 (6.5)	79 (7.1)
Sex: Female, Male (Count of Participants)
Female	19 82.6%	19 90.5%	38 86.4%
Male	4 17.4%	2 9.5%	6 13.6%
Region of Enrollment (Count of Participants)
United States	23 100%	21 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Description	The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame	Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery

Outcome Measure Data

Analysis Population Description

From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
Measure Participants	18	18
Mean (Standard Deviation) [units on a scale]	15 (4)	14 (5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments	Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change in RDQ in the Bipedicular Group From 3 to 12 Months
Description	The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.
Time Frame	3-12 months post operation

Outcome Measure Data

Analysis Population Description

From the period of intervention to 12 month follow-up, 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.

Arm/Group Title	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered deliver bone cement. A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Measure Participants	15
Mean (Standard Deviation) [units on a scale]	4.7 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Description	Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.
Time Frame	Preoperative assessment within 3 weeks before surgery and postoperative day 1

Outcome Measure Data

Analysis Population Description

Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
Measure Participants	14	17
Mean (Standard Deviation) [percent change]	20.5 (15)	14.8 (10.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty
Description	Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery
Time Frame	Preoperative assessment within 3 weeks before surgery and postoperative day 1

Outcome Measure Data

Analysis Population Description

Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
Measure Participants	14	17
Mean (Standard Deviation) [percent change]	4.80 (4.0)	4.70 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Description	The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.
Time Frame	3 months post-op

Outcome Measure Data

Analysis Population Description

From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. A guidewire was placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Measure Participants	18	18
Mean (Standard Deviation) [units on a scale]	11.2 (2.3)	8.1 (3.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Description	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain
Time Frame	3 months post-op

Outcome Measure Data

Analysis Population Description

From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Measure Participants	18	18
Mean (Standard Deviation) [units on a scale]	4.3 (2.6)	3.9 (2.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Description	Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.[2] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible
Time Frame	12 months post-op

Outcome Measure Data

Analysis Population Description

From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Measure Participants	14	15
Mean (Standard Deviation) [units on a scale]	14.8 (10.2)	14.1 (9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.90
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Description	The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.
Time Frame	12 months post-op

Outcome Measure Data

Analysis Population Description

From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Measure Participants	14	15
Mean (Standard Deviation) [units on a scale]	8.1 (11.2)	6.7 (9.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.36
	Comments
	Method	t-test, 2 sided
	Comments

9. Secondary Outcome

Title	Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Description	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain
Time Frame	12 months post-op

Outcome Measure Data

Analysis Population Description

From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Measure Participants	14	15
Mean (Standard Deviation) [units on a scale]	3.7 (1.9)	3.5 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Description	Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.
Time Frame	Preoperative assessment within 3 weeks before surgery and postoperative day 1

Outcome Measure Data

Analysis Population Description

Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.

Arm/Group Title	Unipedicular Kyphoplasty	Bipedicular Kyphoplasty Group
Arm/Group Description	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement. Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated.
Measure Participants	14	17
Mean (Standard Deviation) [percent change]	17.8 (12.8)	13.7 (8.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unipedicular Kyphoplasty, Bipedicular Kyphoplasty Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Unipedicular Kyphoplasty		Bipedicular Kyphoplasty Group
Arm/Group Description	Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.		Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA): A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
All Cause Mortality
	Unipedicular Kyphoplasty		Bipedicular Kyphoplasty Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Unipedicular Kyphoplasty		Bipedicular Kyphoplasty Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Unipedicular Kyphoplasty		Bipedicular Kyphoplasty Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.