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Total Facet Arthroplasty System®(TFAS®) Clinical Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Archus Orthopedics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Archus Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT00418197
First received: January 2, 2007
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Archus Orthopedics, Inc.:

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.

Estimated Enrollment: 450
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418197     History of Changes
Other Study ID Numbers: PR0051
Study First Received: January 2, 2007
Last Updated: February 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Archus Orthopedics, Inc.:
spinal stenosis
low back pain
spondylolisthesis
lumbar spinal stenosis
leg pain
spinal diseases

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Constriction, Pathologic
Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on September 18, 2014