Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02441959
Status:
TERMINATED
Last Update Posted:
2018-08-07
First Post:
2015-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Investigator Moved Institutions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leg pain as assessed by VAS score', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the clinical and radiographic outcomes of full endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar herniated discs in which the patient's leg pain is greater than back pain.", 'detailedDescription': 'The study will be performed utilizing a prospective multi-center randomized model. Approximately 7 centers will be included in the study as listed above. Patients will be informed of clinical trial and asked if they would like to participate. Patients are informed that participation is optional. Patients may withdraw from study any time prior to or after surgery. Patients will be randomized 2:1 ratio endoscopic:open surgery. Both the endoscopic and open surgical techniques are utilized in standard of care. If a subject requires an open surgery approach (based on the surgeons assessment at the time of surgery pre or post incision) after they are randomized to the endoscopic arm, they will be switched to the open arm and included in the open crossover arm of the study.\n\nStudy procedures will occur at the following time points; Pre-op, 6 wk, 3 mon, 6 mon, 1 yr and 2 yr follow-up.Subjects will complete questionnaires that assess pain level and location, functional capacity, work and health status, medication usage and duration of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient equal to or greater than 18 years old.\n2. Patients with single level para-central herniated discs from L1-S1.\n3. VAS (Visual Analog Scale) leg \\> 40 mm.\n4. Leg pain must be greater than back pain.\n5. Minimum 6 weeks conservative treatment unless motor strength U\\< U4/5 and or deteriorating neurologic function.\n\nExclusion Criteria:\n\n1. Lateral/subarticular, far lateral disc herniations\n2. Multi-focal (multi modal) disc herniations\n3. Symptomatic multiple level disc herniations\n4. Active infection either spinal or otherwise\n5. Prior history of lumbar spinal infection at any level\n6. Spinal tumor in lumbar region\n7. Dynamic (any grade) or fixed spondylolisthesis more than 3mm\n8. Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level\n9. Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level\n10. Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)\n11. Disc herniation which is significantly calcified\n12. Contra-lateral leg pain U\\>40 mm\n13. History of peripheral diabetic neuropathy\n14. Significant central stenosis with history of neurogenic claudication\n15. Pregnancy\n16. Facet cyst on symptomatic side\n17. Cauda Equina syndrome past or present\n18. Patients cannot have had prior lumbar surgery including IDET (Intradiscal Electrothermal Therapy) or other percutaneous surgical procedures.\n19. Significant vascular claudication\n20. History of radiation to the spinal column\n21. History of malignancy of any type within 2 years of consideration of enrollment'}, 'identificationModule': {'nctId': 'NCT02441959', 'briefTitle': 'Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study', 'orgStudyIdInfo': {'id': '1504015767'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic Discectomy', 'description': 'Randomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug', 'interventionNames': ['Procedure: Lumbar discectomy Endoscopic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Discectomy', 'description': 'Randomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug', 'interventionNames': ['Procedure: Lumbar discectomy Open']}, {'type': 'OTHER', 'label': 'Open Discectomy-Cross Over Arm', 'description': 'Randomized to Endoscopic Discectomy Cross over to lumbar discectomy open based on surgeons assessment pre or post incision Intervention type is lumbar open surgery- no device or drug', 'interventionNames': ['Procedure: Lumbar discectomy Open']}], 'interventions': [{'name': 'Lumbar discectomy Open', 'type': 'PROCEDURE', 'otherNames': ['Intervention type is lumbar Open surgery- no device or drug'], 'description': 'Open Discectomy', 'armGroupLabels': ['Open Discectomy', 'Open Discectomy-Cross Over Arm']}, {'name': 'Lumbar discectomy Endoscopic', 'type': 'PROCEDURE', 'otherNames': ['(Intervention type is lumbar endoscopic surgery- no device or drug'], 'description': 'Endoscopic Discectomy', 'armGroupLabels': ['Endoscopic Discectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'James J Yue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Desert Institute for Spine Care', 'class': 'UNKNOWN'}, {'name': 'Trinity Spine Center', 'class': 'UNKNOWN'}, {'name': 'Baton Rouge Ortho Clinic', 'class': 'UNKNOWN'}, {'name': 'Orthopedic and Neurological Consultants, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}