Total Facet Arthroplasty System®(TFAS®) Clinical Trial
Primary Purpose
Spinal Stenosis, Low Back Pain, Spondylolisthesis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Total Facet Arthroplasty System® (TFAS®)
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis focused on measuring spinal stenosis, low back pain, spondylolisthesis, lumbar spinal stenosis, leg pain, spinal diseases
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
The primary safety and efficacy evaluation endpoints to determine individual patient success are the Zurich Claudication Questionnaire (ZCQ), neurologic status, solid fusion for the control (spinal fusion) group.
Secondary Outcome Measures
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.
Full Information
NCT ID
NCT00418197
First Posted
January 2, 2007
Last Updated
February 4, 2009
Sponsor
Archus Orthopedics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00418197
Brief Title
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
Official Title
A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Archus Orthopedics, Inc.
4. Oversight
5. Study Description
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 following surgical removal. TFAS® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Low Back Pain, Spondylolisthesis, Lumbar Spinal Stenosis, Leg Pain, Spinal Diseases
Keywords
spinal stenosis, low back pain, spondylolisthesis, lumbar spinal stenosis, leg pain, spinal diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Total Facet Arthroplasty System® (TFAS®)
Primary Outcome Measure Information:
Title
The primary safety and efficacy evaluation endpoints to determine individual patient success are the Zurich Claudication Questionnaire (ZCQ), neurologic status, solid fusion for the control (spinal fusion) group.
Secondary Outcome Measure Information:
Title
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
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