Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-24 @ 4:00 AM
Study NCT ID:
NCT02457468
Status:
COMPLETED
Last Update Posted:
2019-12-24
First Post:
2015-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2015-05-10', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery', 'timeFrame': '5 years', 'description': 'The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points'}, {'measure': 'Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;', 'timeFrame': '5 years', 'description': 'Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.'}, {'measure': 'Patient has not had any major device related complications', 'timeFrame': '5 years', 'description': 'Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.'}, {'measure': 'Patient has not undergone any Epidural injections', 'timeFrame': '5 years', 'description': 'Assessment of lumbar epidural injections'}], 'secondaryOutcomes': [{'measure': 'Zurich Claudication Questionnaire (ZCQ)', 'timeFrame': '5 years', 'description': 'ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.'}, {'measure': 'Quality of Life', 'timeFrame': '5 years', 'description': "Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L"}, {'measure': 'VAS Leg Pain', 'timeFrame': '5 years', 'description': 'Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).'}, {'measure': 'VAS Back Pain', 'timeFrame': '5 years', 'description': 'Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coflex', 'interlaminar stabilization', 'lumbar spinal stenosis', 'neurogenic claudication', 'decompression'], 'conditions': ['Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;\n2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.\n\nExclusion Criteria:\n\n1. Prior fusion or decompressive laminectomy at any index lumbar level;\n2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);\n3. Severe facet hypertrophy that requires extensive bone removal which would cause instability;\n4. Grade II or greater spondylolisthesis;\n5. Isthmic spondylolisthesis or spondylolysis (pars fracture);\n6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°);\n7. Osteoporosis;\n8. Back or leg pain of unknown etiology;\n9. Axial back pain only, with no leg, buttock, or groin pain;\n10. Morbid obesity defined as a body mass index \\> 40;\n11. Active or chronic infection - systemic or local;\n12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;\n13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;\n14. Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;\n15. Patient is unwilling to complete his/her surveys.'}, 'identificationModule': {'nctId': 'NCT02457468', 'briefTitle': 'The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology', 'organization': {'class': 'OTHER', 'fullName': 'Predicted, Reported and Observed Outcomes Foundation'}, 'officialTitle': 'The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology', 'orgStudyIdInfo': {'id': 'SR-2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stenosis patients treated with coflex', 'description': 'Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression', 'interventionNames': ['Device: coflex']}], 'interventions': [{'name': 'coflex', 'type': 'DEVICE', 'armGroupLabels': ['Stenosis patients treated with coflex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Neurology and Spine', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85225', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Brain and Spine', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'The Spine Institute, Center for Spine Restoration', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33306', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Cantor Spine institute', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Southeastern Integrated Medical', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Orthopaedic Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'The BACK Center', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33703', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'All Florida Orthopaedics', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Laser Spine Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'OrthoAtlanta', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '60463', 'city': 'Palos Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Orthospine Center LTD', 'geoPoint': {'lat': 41.66809, 'lon': -87.79644}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Orthopedic Center of Illinois', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Orthopedic Surgeons', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '63017', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Orthopedic Center of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63122', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Orthopedic Sports Medicine & Spine Care Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07649', 'city': 'Oradell', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Brain and Spine Center', 'geoPoint': {'lat': 40.95871, 'lon': -74.03681}}, {'zip': '07083', 'city': 'Union', 'state': 'New Jersey', 'country': 'United States', 'facility': 'IGEA Brain and Spine', 'geoPoint': {'lat': 40.6976, 'lon': -74.2632}}, {'zip': '88201', 'city': 'Roswell', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Spine and Orhtopedic Center of New Mexico', 'geoPoint': {'lat': 33.39437, 'lon': -104.52491}}, {'zip': '13326', 'city': 'Cooperstown', 'state': 'New York', 'country': 'United States', 'facility': 'Bassett Medical Center', 'geoPoint': {'lat': 42.70048, 'lon': -74.92426}}, {'zip': '28704', 'city': 'Arden', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blue Ridge Bone and Joint', 'geoPoint': {'lat': 35.46623, 'lon': -82.51651}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'OrthoNeuro', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '43560', 'city': 'Sylvania', 'state': 'Ohio', 'country': 'United States', 'facility': 'Consulting Orthopaedic Associates', 'geoPoint': {'lat': 41.71894, 'lon': -83.71299}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'OrthoTexas', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '75287', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Spine Care', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98372', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'NeoSpine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '82414', 'city': 'Cody', 'state': 'Wyoming', 'country': 'United States', 'facility': 'Bighorn Medical Center', 'geoPoint': {'lat': 44.52634, 'lon': -109.05653}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Predicted, Reported and Observed Outcomes Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'SPIRITT Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}