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Total Facet Arthroplasty System®(TFAS®) Clinical Trial

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ClinicalTrials.gov Identifier: NCT00418197
Recruitment Status : Unknown
Verified February 2009 by Archus Orthopedics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 4, 2007
Last Update Posted : February 5, 2009
Sponsor:
Information provided by:
Archus Orthopedics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Low Back Pain Spondylolisthesis Lumbar Spinal Stenosis Leg Pain Spinal Diseases Device: Total Facet Arthroplasty System® (TFAS®) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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ClinicalTrials.gov Identifier: NCT00418197    
Other Study ID Numbers: PR0051
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009
Keywords provided by Archus Orthopedics, Inc.:
spinal stenosis
low back pain
spondylolisthesis
 lumbar spinal stenosis
leg pain
spinal diseases
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Back Pain
Low Back Pain
Constriction, Pathologic
Pain
 Neurologic Manifestations
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis