A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
- Conditions
- Lower Back Pain
- Registration Number
- NCT03247166
- Lead Sponsor
- Hillel Yaffe Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Fusion Prevention 24 months The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
Pain Improvement 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 24 months Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Hillel Yaffe Medical Center
🇮🇱H̱adera, Israel
Hillel Yaffe Medical Center🇮🇱H̱adera, IsraelIlana Alony, RNContact972-4-6304487ilanaa@hy.health.gov.il