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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
Archus Orthopedics, Inc.
About
Eligibility
Locations
Outcomes
Full info

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

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 2, 2007
    Last Updated
    February 4, 2009
    Sponsor
    Archus Orthopedics, Inc.
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    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

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    Total Facet Arthroplasty System®(TFAS®) Clinical Trial

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