Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 7:03 AM
Study NCT ID:
NCT01972256
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2013-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011542', 'term': 'Pseudarthrosis'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}, {'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D005599', 'term': 'Fractures, Ununited'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additional Secondary Endpoint: Efficacy', 'timeFrame': 'Assessed at 2 years post-op', 'description': "Comparative Lordosis of L4-S1 at 24-months as determined by an independent orthopedic surgeon reviewer's interpretation of 24-month lateral (neutral) radiographs compared to baseline."}], 'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'Assessed at 2 years post-op or greater', 'description': 'Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '2 years post-op', 'description': 'Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pseudoarthrosis', 'Spinal Stenosis', 'Spondylolisthesis', 'Degenerative Disc Disease (DDD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or bilateral supplemental screw fixation as an adjunct to fusion.\n\nSubject candidates are those who had previously required and received fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).', 'detailedDescription': 'Consecutive subjects who were treated with the transsacral lumbar interbody fusion or TLIF procedures at least 2 years prior to the date the data is collected will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject candidates are those who had required fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years of age or older\n* Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD)\n* Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons\n* Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery\n\nExclusion Criteria:\n\n* Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1\n* Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery'}, 'identificationModule': {'nctId': 'NCT01972256', 'briefTitle': 'A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxano Surgical, Inc.'}, 'officialTitle': 'Prospective Multicenter Clinical Evaluation of Fusion', 'orgStudyIdInfo': {'id': 'PR-0023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Previous transsacral fusion', 'description': 'Subject candidates are those who had required a transsacral fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).'}, {'label': 'Previous transforaminal lumbar interbody fusion', 'description': 'Subject candidates are those who had required transforaminal lumbar interbody fusion at L4-L5-S1 where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33637', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Foundation for Orthopaedic Research and Education', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46032', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Spine Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Bone and Joint Clinic of Baton Rouge', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '48327', 'city': 'Waterford', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Spine Institute', 'geoPoint': {'lat': 42.69303, 'lon': -83.41181}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Brazos Spine', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxano Surgical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}