Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT00292292
Status:
TERMINATED
Last Update Posted:
2013-09-13
First Post:
2006-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}}, 'statusModule': {'whyStopped': 'Economic and business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2011-07-19', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-31', 'studyFirstSubmitDate': '2006-02-13', 'dispFirstSubmitQcDate': '2011-07-19', 'studyFirstSubmitQcDate': '2006-02-14', 'dispFirstPostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Maintenance or improvement in neurologic status', 'timeFrame': '24 months'}, {'measure': 'Pain improvement', 'timeFrame': '24 months'}, {'measure': 'Significant disc height increase', 'timeFrame': '24 months'}, {'measure': 'No displacement or migration of the device', 'timeFrame': '24 months'}, {'measure': 'Time to return to work', 'timeFrame': '24 months'}, {'measure': 'Time to recovery', 'timeFrame': '24 months'}, {'measure': 'Preservation of at least 4 degrees of motion in flexion/extension', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.spinalmotion.com', 'label': 'sponsors web site contains animated information regarding disc'}]}, 'descriptionModule': {'briefSummary': 'The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.', 'detailedDescription': 'The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Summary:\n\n* Be between 18 and 60 years of age\n* Have evidence of degenerative disc disease (DDD)\n* History of back and/or radicular pain which is severe, ongoing and recurrent\n* Minimum 6 month period of prior conservative care\n* Moderate Oswestry Disability Index score\n* Moderate pain score\n* Be likely to return for all follow-up visits\n* Be willing and able to provide Informed Consent for study participation.\n\nExclusion Criteria Summary:\n\n* Any back or leg pain of unknown origin\n* Foot drop\n* Previous trauma to the study treatment level with compression or bursting\n* Previous retroperitoneal surgery\n* Other spinal surgery at affected level except IDET, laminotomy\n* Previous thoracic or lumbar fusion\n* Documented abnormal abdominal vessel or muscular/fascial pathology or morphology\n* Degenerative spondylolisthesis\n* Ischemic (spondylolytic) spondylolisthesis\n* Spondylitis\n* Documented significant spinal, foraminal or lateral stenosis\n* Severely reduced disc space height\n* Documented presence of free nuclear fragment\n* Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray\n* Scoliosis of the lumbar spine\n* Metabolic bone disease\n* Active systemic infection\n* Hepatitis\n* Active malignancy or history of metastatic malignancy\n* Any terminal or autoimmune disease\n* Any other disease, condition or surgery which might impair healing\n* Recent history of chemical or alcohol dependence\n* Current or extended use of any drug known to interfere with bone or soft tissue healing\n* Known metal allergy\n* Morbid obesity\n* Transitional vertebrae at level to be treated that has not clearly fused\n* Currently a prisoner\n* Currently involved in spinal litigation\n* Currently experiencing an episode of major mental illness\n* Pregnancy at time of enrollment, since this would contraindicate abdominal surgery\n* Participation in another drug, diologic or medical trial within 30 days of study surgery\n* Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.'}, 'identificationModule': {'nctId': 'NCT00292292', 'briefTitle': 'Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'SpinalMotion'}, 'officialTitle': 'Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage', 'orgStudyIdInfo': {'id': 'Kineflex'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kineflex Lumbar Artificial Disc', 'description': 'Treatment arm', 'interventionNames': ['Device: Lumbar Artificial Disc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Charite', 'interventionNames': ['Device: Charite Artificial Disc']}], 'interventions': [{'name': 'Lumbar Artificial Disc', 'type': 'DEVICE', 'otherNames': ['Kineflex Disc'], 'description': 'Insertion of the Kineflex Lumbar ArtificialDisc', 'armGroupLabels': ['Kineflex Lumbar Artificial Disc']}, {'name': 'Charite Artificial Disc', 'type': 'DEVICE', 'otherNames': ['SB Charite'], 'description': 'Insertion of the Charite', 'armGroupLabels': ['Charite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Orthopedics and Sports Medicine', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'CORE Orthopaedic Medical Center', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Oakland Regional Spine Surgery', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92408', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Dept. of Orthopaedic Surgery', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Associates in Orthopedic Medicine, P.C.', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Neuro-Spine Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Spine Institute of Louisiana', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Brain and Spine Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Orthopaedic Associates, P.A', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '89509', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Regional Spine Institute', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '13346', 'city': 'Hamilton', 'state': 'New York', 'country': 'United States', 'facility': 'Hamilton Orthopaedic Surgery and Sports Medicine', 'geoPoint': {'lat': 42.82701, 'lon': -75.54462}}, {'zip': '14094', 'city': 'Lockport', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo Spine Surgery', 'geoPoint': {'lat': 43.17061, 'lon': -78.69031}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Orthopaedics, P.C.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Neurosurgery and Spine Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Triangle Orthopaedic Associates, P.A.', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univ. of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Back Institute Clinical Research Organization', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Gordon Spine Associates', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Orthopedics International Spine', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}], 'overallOfficials': [{'name': 'Fred Geisler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Monitor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SpinalMotion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}