Lumbar Spinal Stenosis, Spondylolisthesis
Conditions
Brief summary
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
Detailed description
This study is being conducted to evaluate the TOPS™ SP System from (TOPS™ System or TOPS). TOPS is an alternative to spinal fusion and is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis (abnormal/excessive movement of the vertebrae causing pain in the lower back and legs) and spinal stenosis (narrowing of the spinal canal resulting in compression of nerves producing symptoms of pain, numbness and tingling in the legs).
Interventions
DEVICETOPS System
Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.
Sponsors
Premia Spine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
IInclusion Criteria - Prospective subjects must meet all of the following criteria to be considered eligible for inclusion in this clinic study: * Age 40-85 years old; * One or both of the following at a single level from L3 to L5; (1) symptomatic monosegmental lumbar spinal stenosis or facet arthrosis, (2) degenerative spondylolisthesis up to and including grade 1. * At least three (3) months of failed, conservative treatment prior to surgery (unless deemed inadvisable due to progressive motor weakness or other evidence of rapidly deteriorating condition) including the use of anti-inflammatory medications at maximum specified dosage, administration of epidural/facet injections, rest, heat, electrotherapy and/or physical therapy; * Narrowing of the lumbar spinal canal (central and/or foramenal) classified as moderate to severe using CT scans/MRI; * VAS leg pain of at least 40/100; * Oswestry Disability Index score of at least 40/100; * Lower back pain or sciatica with or without spinal claudication and * Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
Exclusion criteria
- Prospective subjects must not meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in ODI and Improvement in VAS leg score v | 24 months post implantation | Composite endpoint - Subjects who exhibit a reduction of 15 percent in their Oswestry Disability Index (ODI) score compared to their preoperative ODI score AND a reduction of at least 20mm (20% improvement) in either of their VAS Leg Score will be considered a success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in back and leg visual analog scales (VAS) | 24 month postoperatively | A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention. |
| Improvement in ZCQ scores | 24 months postoperatively | A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention. |
| Quality of life (SF-36) | 24 months postoperatively | A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention. |
| Maintenance or improvement in neurological symptoms | 24 months postoperatively | A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention. |
Countries
United Kingdom
Contacts
Primary ContactMasood Shafafy, MD
Outcome results
None listed