Status:
UNKNOWN
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
Lead Sponsor:
Archus Orthopedics, Inc.
Conditions:
Spinal Stenosis
Low Back Pain
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets follo...
Eligibility Criteria
Inclusion
- Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5
- Skeletally mature male or female between the ages of 50 and 85 years of age inclusive
- No greater than Grade I degenerative spondylolisthesis at the index level
- Persistent leg symptoms,including pain, numbness, burning or tingling for a minimum duration of six months
- Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression
- Failed to respond to non-operative treatment modalities for a minimum duration of six months
Exclusion
- Male or female less than 50 or greater than 85 years old Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level
- More than 3 vertebral levels of degenerative spinal stenosis requiring decompression
- More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation
- Not available for long term follow-up and interval visits
- Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine
- Two or more previous surgeries to the lumbar spine at the same level to be implanted
- Is being treated with other devices for the same disorder (e.g. pain control devices)
- Active systemic infection or infection at the operating site
- Osteoporosis
- Known sensitivity to device materials
- Has an immunosuppressive disorder
- Has a medical condition that may interfere with clinical evaluations
- Is obese defined by a patient body mass index greater than 40
- Has significant scoliosis (Cobb \>25°)
- Is pregnant or planning to become pregnant within the proposed three year investigation
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00418197
Start Date
August 1 2005
Last Update
February 5 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.