Spinal StenosisPhase 3NCT00418197
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
A Phase 3 study testing Total Facet Arthroplasty System® (TFAS®) in people with Spinal Stenosis and Low Back Pain, run by Archus Orthopedics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Spinal Stenosis, Low Back Pain, Spondylolisthesis
- What is being tested?
- Total Facet Arthroplasty System® (TFAS®)
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
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.
- Conditions
- Spinal Stenosis, Low Back Pain, Spondylolisthesis, Lumbar Spinal Stenosis, Leg Pain, Spinal Diseases
- Being tested
- Total Facet Arthroplasty System® (TFAS®)
- Keywords
- spinal stenosis, low back pain, spondylolisthesis, lumbar spinal stenosis, leg pain, spinal diseases
- Medical subject headings
- Spinal Stenosis, Low Back Pain, Spondylolisthesis, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Facet Arthroplasty System® (TFAS®)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Archus Orthopedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418197
- Sponsor's protocol ID
- PR0051
- Status last verified
- Feb 2009
- First submitted
- 2 Jan 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00418197
- Acronym / sponsor ID
- PR0051
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Archus Orthopedics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Facet Arthroplasty System® (TFAS®) | Device | – |
Primary outcome
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.
1 secondary outcome
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Total Facet Arthroplasty System® (TFAS®) in people with Spinal Stenosis and Low Back Pain, run by Archus Orthopedics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.