Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00444405
Status:
WITHDRAWN
Last Update Posted:
2020-02-27
First Post:
2007-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI left Health System', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2007-03-06', 'studyFirstSubmitQcDate': '2007-03-06', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lumbar', 'disc', 'herniation', 'discectomy', 'fusion', 'spine'], 'conditions': ['Low Back Pain', 'Recurrent Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.', 'detailedDescription': 'Lumbar disc herniations are quite common and typically improve after surgical correction. However, some patients develop recurrent herniations at the same level. Controversy exists as to why reherniated discs occur. Moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. This study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with recurrent lumbar disc herniation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent lumbar disc herniation by MRI or CT with history of decompression at the same level in the past\n* Recurrent symptomatic history (with or without back pain) with radicular leg pain that improved following the first surgery\n* Male or female 18-75 years old\n* Flexion and extension x-rays that demonstrate an absence of sponylolisthesis or spondylolisthesis with less than 3 mm of movement\n\nExclusion Criteria:\n\n* Recurrence of disc herniation within 3 months of first decompression\n* Multiple level herniated discs\n* No history of lumbar back surgery except as in Inclusion criteria above\n* Documented severe osteoporosis or osteopenia\n* Symptoms of low back pain only\n* Diabetes mellitus\n* Patients with suspected or diagnosed psychological/psychiatric problems that could compromise the reliability of their results\n* Lumbar spondylolisthesis on flexion/extension x-rays \\> 3 mm\n* History of lumbar spine fractures (new or old)\n* Any concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study\n* Autoimmune diseases\n* Age less than 18 or greater than 75 years'}, 'identificationModule': {'nctId': 'NCT00444405', 'briefTitle': 'Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Research'}, 'officialTitle': 'Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation', 'orgStudyIdInfo': {'id': 'SJCNS-01'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alan M. Scarrow, MD, JD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Health System, Missouri"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Manager - Mercy Research', 'investigatorFullName': 'Michelle McFarland, MPH, CHRC', 'investigatorAffiliation': 'Mercy Research'}}}}