Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 2:19 PM
Study NCT ID:
NCT00759057
Status:
TERMINATED
Last Update Posted:
2012-06-28
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of the Dynesys(R) Spinal System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-03-03', 'releaseDate': '2020-02-19'}], 'estimatedResultsFirstSubmitDate': '2020-02-19'}}, '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'whyStopped': 'PMA not approved. FDA granted permission to close the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2008-09-23', 'studyFirstSubmitQcDate': '2008-09-23', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)', 'timeFrame': '24 Months'}], 'secondaryOutcomes': [{'measure': 'Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal Stenosis', 'Spinal Instability', 'Leg Pain'], 'conditions': ['Degenerative Spondylolisthesis or Retrolisthesis', 'Spinal Stenosis', 'Stenosing Lesion.']}, 'descriptionModule': {'briefSummary': 'This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.', 'detailedDescription': 'The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having degenerative spondylolisthesis or retrolisthesis (up to Grade 1) AND/OR Patients having lateral or central spinal stenosis or other stenosing lesion as diagnosed by radiculopathic signs, neurogenic claudication or imaging studies;\n* Candidate for single-level or contiguous two-level PLF between L1-S1;\n* Patients have a predominate component of leg rather than back symptoms; symptoms include pain, muscle weakness, and/or sensation abnormality as evidenced by patient history and diagnostic studies.\n* Patients may require decompression at the levels considered for treatment\n* Pre-operative leg pain score greater than or equal to 40 mm on a 100 mm Visual Analog Scale (VAS);\n* Leg pain must be unresponsive to conservative (non-surgical) management for minimum of 3 months;\n* Pre-operative Oswestry score greater than or equal to 30 indicating at least moderate disability;\n* Skeletally mature individual between ages 20 and 80;\n* Must be willing and able to comply with study requirements; including willing and able to sign a study-specific, IRB-approved informed consent form, complete necessary study paperwork and return for required follow-up visits.\n\nExclusion Criteria:\n\n* Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered;\n* Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;\n* Degenerative scoliosis greater than 10 degrees at the affected motion segment;\n* Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);\n* Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);\n* Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s);\n* Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s);\n* Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A);\n* Active local or systemic infection;\n* Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan to confirm adequate bone density;\n* Receiving immunosuppressive or long-term steroid therapy;\n* Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery;\n* Documented history of titanium alloy, PET or PCU allergy, or intolerance;\n* Active malignancy or other significant medical comorbidities;\n* Current chemical dependency or significant emotional and/or psychosocial disturbance that may impact treatment outcome or study participation as evidenced by three or more positive Waddell Signs;\n* Pregnancy;\n* Incarceration;\n* Severe muscular, neural or vascular diseases that endanger the spinal column;\n* Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible;\n* All concomitant diseases that can jeopardize the functioning and success of the patient;\n* Vertebral fractures;\n* Treatment of the thoracic and cervical spine;\n* Severely deformed anatomy due to congenital anomalies;\n* Paralysis'}, 'identificationModule': {'nctId': 'NCT00759057', 'briefTitle': 'A Clinical Study of the Dynesys(R) Spinal System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization', 'orgStudyIdInfo': {'id': 'G020291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 - Investigational', 'description': 'Dynesys Non-Fusion Spinal System', 'interventionNames': ['Device: Posterior Pedicle Screw System']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 - Control', 'description': 'Silhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft.', 'interventionNames': ['Device: Posterior Pedicle Screw System']}], 'interventions': [{'name': 'Posterior Pedicle Screw System', 'type': 'DEVICE', 'description': 'Implantation of Posterior Pedicle Screw System', 'armGroupLabels': ['1 - Investigational', '2 - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Spine Center', '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': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center, The Spine Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95350', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Regional Neurosurgery', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Spine Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medical Faculty Associates - The George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopedic Care & Sports Medicine Center', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Peachtree Orthopaedic Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Orthopedic', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Neurosurgical', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Spine and Hand Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '70810', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Spine Specialty Center (SSC)', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore Neurosurgical Associates, PA', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Orthopaedic Associates', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '01960', 'city': 'Peabody', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Sports Medicine North', 'geoPoint': {'lat': 42.52787, 'lon': -70.92866}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Orthopedic Consultants, PA', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Orthopaedics, PC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13202', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University Dept of Orthopedic Surgery', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Triangle Orthopedic Associates', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Orthopaedic Spine Associates', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '15213-2582', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dept. of Neurosurgery UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19090', 'city': 'Willow Grove', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Hospital', 'geoPoint': {'lat': 40.144, 'lon': -75.11573}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'SPINE', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'College Station Neurosurgery', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Park Plaza Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'SpineMark CRO at TBI', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-02-19', 'type': 'RELEASE'}, {'date': '2020-03-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zimmer Biomet'}}}}