Status:
UNKNOWN
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Lead Sponsor:
Hillel Yaffe Medical Center
Conditions:
Lower Back Pain
Eligibility:
All Genders
40-85 years
Phase:
NA
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 cl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03247166
Start Date
September 1 2017
End Date
September 1 2019
Last Update
August 11 2017
Active Locations (1)
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1
Hillel Yaffe Medical Center
Hadera, Israel, 38100