Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-04 @ 6:37 PM
Study NCT ID:
NCT00252551
Status:
TERMINATED
Last Update Posted:
2015-03-17
First Post:
2005-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-15', 'studyFirstSubmitDate': '2005-11-10', 'studyFirstSubmitQcDate': '2005-11-10', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylisthesis', 'timeFrame': 'M3, M12, M18'}], 'secondaryOutcomes': [{'measure': "improvement of patients' Quality of Life (SF36)", 'timeFrame': 'M18'}, {'measure': 'radiologic stability of spondylolisthesis', 'timeFrame': 'M18'}, {'measure': 'safety of the used surgical procedures', 'timeFrame': 'M3, M12, M18'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spondylolisthesis, decompressive surgery, osteosynthesis'], 'conditions': ['Spondylolisthesis']}, 'referencesModule': {'references': [{'pmid': '1403105', 'type': 'BACKGROUND', 'citation': 'Caputy AJ, Luessenhop AJ. Long-term evaluation of decompressive surgery for degenerative lumbar stenosis. J Neurosurg. 1992 Nov;77(5):669-76. doi: 10.3171/jns.1992.77.5.0669.'}, {'pmid': '8073310', 'type': 'BACKGROUND', 'citation': 'Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1201-6. doi: 10.1097/00007632-199405310-00001.'}, {'pmid': '8059266', 'type': 'BACKGROUND', 'citation': 'Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.'}, {'pmid': '3992350', 'type': 'BACKGROUND', 'citation': 'Feffer HL, Wiesel SW, Cuckler JM, Rothman RH. Degenerative spondylolisthesis. To fuse or not to fuse. Spine (Phila Pa 1976). 1985 Apr;10(3):287-9.'}, {'pmid': '11725230', 'type': 'BACKGROUND', 'citation': 'Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002.'}, {'pmid': '10488513', 'type': 'BACKGROUND', 'citation': 'Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32. doi: 10.1097/00007632-199909010-00012.'}]}, 'descriptionModule': {'briefSummary': 'Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis', 'detailedDescription': "Randomized, comparative study on 152 patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months.\n\nPatients randomized in 2 parallel groups (each group with 76 patients)\n\n* one group with decompressive surgery + osteosynthesis\n* one group with decompressive surgery Study duration : 18 months, including a selection visit, an inclusion with the surgical intervention, 3, 12, 18 months' follow up visits and a follow up call at 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months;\n* Patients who agree to take part in the study and to sign an Informed Consent Form\n\nExclusion Criteria:\n\n* Contre-indications to surgery or to vertebral isolated fixation L4-L5\n* Previous lumbar surgery\n* Work accidents\n* Psychiatric troubles that may interfere with the clinical evaluation\n* Pregnant women or women who could be pregnant during the study\n* Patient under special supervision or trusteeship\n* Refusal to sign the Informed Consent Form\n* No Public Health Insurance cover'}, 'identificationModule': {'nctId': 'NCT00252551', 'acronym': 'CLEOS', 'briefTitle': 'Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study', 'orgStudyIdInfo': {'id': '0300201'}, 'secondaryIdInfos': [{'id': 'PHRC0300201', 'type': 'OTHER_GRANT', 'domain': 'French Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'osteosynthesis', 'interventionNames': ['Procedure: Osteosynthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Simple surgery', 'interventionNames': ['Procedure: Simple surgery']}], 'interventions': [{'name': 'Osteosynthesis', 'type': 'PROCEDURE', 'armGroupLabels': ['1']}, {'name': 'Simple surgery', 'type': 'PROCEDURE', 'description': 'Surgery without device', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'University Hospital of Besançon - Neurosurgey department', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'University Hospital of Caen - Neurosurgery department', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'University Hospital of Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '34094', 'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique Rech - Neurosurgery centre', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'University Hospital of Nice - Neurosurgery department', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'University Hospital of Saint-Etienne - Neurosurgery department', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'University Hospital of Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse University Hospital - Purpan - Neurosurgery department', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse University Hospital - Rangueil- Neuro surgery department', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jacques Lagarrigue', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}