An interventional study of TOPS™ System in Lower Back Pain, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-11.
Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Treatment
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
Device: TOPS™ System
The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints
Pain Improvement
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Time frame: 24 months
Function Improvement
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Time frame: 24 months
Fusion Prevention
The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
Time frame: 24 months
Safety
Subjects with no serious device complications as defined in the radiological protocol
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Hillel Yaffe Medical Center