Total Facet Arthroplasty System®(TFAS®) Clinical Trial

February 4, 2009 updated by: Archus Orthopedics, Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
Visual Analog Scales (VAS) for Leg and Back pain, SF-36 scores, radiographic measurements.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Archus Orthopedics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 2, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

February 5, 2009

Last Update Submitted That Met QC Criteria

February 4, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR0051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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