A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Back Pain
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Fusion Prevention
- Last Updated
- 8 years ago
Overview
Brief Summary
The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis
- •Patients with degenerative spondylolisthesis
- •Patients with at least 3 months failed conservative treatment
- •Narrowing of the lumbar spinal canal
- •Patients with lower back pain or sciatica
Exclusion Criteria
- •Discogenic back pain at TOPS System level
- •Back or non-radicular leg pain of unknown etiology at TOPS System level
- •Lytic spondylolisthesis at TOPS System level
- •More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure
- •Known allergy to titanium and/or polyurethane
Outcomes
Primary Outcomes
Fusion Prevention
Time Frame: 24 months
The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
Pain Improvement
Time Frame: 24 months
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Function Improvement
Time Frame: 24 months
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score