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Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

Sponsor
Zenoss Co, Ltd (Other)
Overall Status
Completed
CT.gov ID
NCT02485574
Collaborator
(none)
69
Enrollment
1
Location
2
Arms
51
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transforaminal lumbar interbody arthrodesis
 N/A

Detailed Description

A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone.

Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan.

The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Left cage- auto bone

At the operated segment, left cage was filled with auto bone only. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.

Procedure: transforaminal lumbar interbody arthrodesis
Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
Other Names:
  • β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss)
  • Auto-local bone

    		•
    Experimental: Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite

    At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.

    Procedure: transforaminal lumbar interbody arthrodesis
    Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
    Other Names:
  • β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss)
  • Auto-local bone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. InCBB of Both Cages [12 month postoperatively]

      We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).

    Secondary Outcome Measures

    1. ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone [12 month postoperatively]

      We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient.

    Other Outcome Measures

    1. ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score) [postoperative 1 year]

      The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability)

    • Patients who have no communication problems

    • Patients who are willing to visit the hospital for any follow-up assessment

    • Patients who voluntarily sign on a written consent

    Exclusion Criteria:

    • Patients who have infection

    • Patients who have bleeding disorders

    • Patients who have immunosuppressed disease

    • Patients who can't sign on consent form

    • Patients who are in pregnancy or breast feeding

    • Patients who have severe osteoporosis

    • Patients who can't take general surgery because of severe liver disease or decreased renal function

    • Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kwang Sup Song Seoul Korea, Republic of

    Sponsors and Collaborators

    • Zenoss Co, Ltd

    Investigators

    • Principal Investigator: Kwang Sup Song, M.D., PhD, Chung-Ang University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Kwang Sup Song, Professor, Zenoss Co, Ltd
    ClinicalTrials.gov Identifier:
    NCT02485574
    Other Study ID Numbers:
    • KSong
    First Posted:
    Jun 30, 2015
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kwang Sup Song, Professor, Zenoss Co, Ltd
    Bone bridging
    Arthrodesis
    Lumbar
    Cage
    Additional relevant MeSH terms:
    Calcium

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title All Study Participants - Single Group
    Arm/Group Description Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted in "same segment". We compared the anterior bone bridging patterns of two cages "at single operated segment" in each patient.
    Period Title: Overall Study
    STARTED 69
    COMPLETED 65
    NOT COMPLETED 4

    Baseline Characteristics

    Arm/Group Title All Study Participants
    Arm/Group Description Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted. We compared the anterior bone bridging patterns of two cages in each patient.
    Overall Participants 69
    Age (years) [Mean (Inter-Quartile Range) ]
    Mean (Inter-Quartile Range) [years]
    66.7
    Sex: Female, Male (Count of Participants)
    Female
    45
    65.2%
    Male
    24
    34.8%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (Count of Participants)
    South Korea
    65
    94.2%
    body mass index (kg/m^2) [Mean (Inter-Quartile Range) ]
    Mean (Inter-Quartile Range) [kg/m^2]
    25.3

    Outcome Measures

    1. Primary Outcome
    Title InCBB of Both Cages
    Description We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).
    Time Frame 12 month postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Left Cage- Auto Bone Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite
    Arm/Group Description Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only. Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
    Measure Participants 65 65
    Mean (95% Confidence Interval) [score on a scale]
    1.48
    1.43
    2. Secondary Outcome
    Title ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone
    Description We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient.
    Time Frame 12 month postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Left Cage- Auto Bonegroup Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite
    Arm/Group Description Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only. Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
    Measure Participants 65 65
    Mean (95% Confidence Interval) [number of anterior holes]
    1.80
    1.85
    3. Other Pre-specified Outcome
    Title ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score)
    Description The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. 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 postoperative 1 year

    Outcome Measure Data

    Analysis Population Description
    Of the total 65 patients, 56 were classified as having interbody fusion, and 9 were classified as not having interbody fusion.
    Arm/Group Title Interbody Fused Group Interbody Unfused Group
    Arm/Group Description We determined the interbody fusion as "in cases with at least one or more complete InCBB and/or ExCBB on both sagittal and coronal views simultaneously without subsidence". This group was classified as having achieved interbody fusion. We determined the interbody fusion in cases with at least one or more complete InCBB and/or ExCBB on both sagittal and coronal views simultaneously without subsidence. This group was classified as not having achieved interbody fusion.
    Measure Participants 56 9
    Mean (95% Confidence Interval) [score on a scale]
    45.53
    35.19

    Adverse Events

    Time Frame 1 year
    Adverse Event Reporting Description
    Arm/Group Title Left Cage- Auto Bone Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite
    Arm/Group Description Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only. Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
    All Cause Mortality
    Left Cage- Auto Bone Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/65 (0%) 0/65 (0%)
    Serious Adverse Events
    Left Cage- Auto Bone Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/65 (0%) 0/65 (0%)
    Other (Not Including Serious) Adverse Events
    Left Cage- Auto Bone Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/65 (0%) 0/65 (0%)

    Limitations/Caveats

    Suggested criterios can only be used for interbody fusion evaluation.

    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.

    Results Point of Contact

    Name/Title Kwang-Sup Song
    Organization Chung-Ang University hospital
    Phone +82-1037616503
    Email ksong70@cau.ac.kr
    Responsible Party:
    Kwang Sup Song, Professor, Zenoss Co, Ltd
    ClinicalTrials.gov Identifier:
    NCT02485574
    Other Study ID Numbers:
    • KSong
    First Posted:
    Jun 30, 2015
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021