A Clinical Study of the Dynesys(R) Spinal System
- Conditions
- Degenerative Spondylolisthesis or RetrolisthesisSpinal StenosisStenosing Lesion.
- Interventions
- Device: Posterior Pedicle Screw System
- Registration Number
- NCT00759057
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 399
- 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;
- Candidate for single-level or contiguous two-level PLF between L1-S1;
- 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.
- Patients may require decompression at the levels considered for treatment
- Pre-operative leg pain score greater than or equal to 40 mm on a 100 mm Visual Analog Scale (VAS);
- Leg pain must be unresponsive to conservative (non-surgical) management for minimum of 3 months;
- Pre-operative Oswestry score greater than or equal to 30 indicating at least moderate disability;
- Skeletally mature individual between ages 20 and 80;
- 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.
- 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;
- Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;
- Degenerative scoliosis greater than 10 degrees at the affected motion segment;
- Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);
- Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);
- Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s);
- Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s);
- Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A);
- Active local or systemic infection;
- Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan to confirm adequate bone density;
- Receiving immunosuppressive or long-term steroid therapy;
- 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;
- Documented history of titanium alloy, PET or PCU allergy, or intolerance;
- Active malignancy or other significant medical comorbidities;
- 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;
- Pregnancy;
- Incarceration;
- Severe muscular, neural or vascular diseases that endanger the spinal column;
- Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible;
- All concomitant diseases that can jeopardize the functioning and success of the patient;
- Vertebral fractures;
- Treatment of the thoracic and cervical spine;
- Severely deformed anatomy due to congenital anomalies;
- Paralysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 - Control Posterior Pedicle Screw System Silhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft. 1 - Investigational Posterior Pedicle Screw System Dynesys Non-Fusion Spinal System
- Primary Outcome Measures
Name Time Method Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status) 24 Months
- Secondary Outcome Measures
Name Time Method Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception 24 Months
Trial Locations
- Locations (26)
Indiana University Neurosurgical
🇺🇸Indianapolis, Indiana, United States
Park Plaza Hospital
🇺🇸Houston, Texas, United States
Heartland Spine and Hand Center
🇺🇸Overland Park, Kansas, United States
Medical Faculty Associates - The George Washington University
🇺🇸Washington, District of Columbia, United States
SpineMark CRO at TBI
🇺🇸Plano, Texas, United States
Denver Spine Center
🇺🇸Denver, Colorado, United States
SUNY Upstate Medical University Dept of Orthopedic Surgery
🇺🇸Syracuse, New York, United States
Triangle Orthopedic Associates
🇺🇸Durham, North Carolina, United States
Dept. of Neurosurgery UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Scottsdale Spine Center
🇺🇸Scottsdale, Arizona, United States
Northwest NeuroSpecialists
🇺🇸Tucson, Arizona, United States
Cedars-Sinai Medical Center, The Spine Institute
🇺🇸Los Angeles, California, United States
Pacific Regional Neurosurgery
🇺🇸Modesto, California, United States
Orthopedic Care & Sports Medicine Center
🇺🇸Aventura, Florida, United States
Orthopaedic Spine Associates
🇺🇸Eugene, Oregon, United States
Fort Wayne Orthopedic
🇺🇸Fort Wayne, Indiana, United States
Abington Hospital
🇺🇸Willow Grove, Pennsylvania, United States
Spine Specialty Center (SSC)
🇺🇸Baton Rouge, Louisiana, United States
Baltimore Neurosurgical Associates, PA
🇺🇸Baltimore, Maryland, United States
Orthopaedic Associates
🇺🇸Towson, Maryland, United States
Sports Medicine North
🇺🇸Peabody, Massachusetts, United States
Orthopedic Consultants, PA
🇺🇸Edina, Minnesota, United States
Manhattan Orthopaedics, PC
🇺🇸New York, New York, United States
Peachtree Orthopaedic Clinic
🇺🇸Atlanta, Georgia, United States
SPINE
🇺🇸Mt. Pleasant, South Carolina, United States
College Station Neurosurgery
🇺🇸College Station, Texas, United States