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Total Facet Arthroplasty System®(TFAS®) Clinical Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 2, 2007

Last Updated Date

February 4, 2009

Start Date ^ICMJE

August 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00418197 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Total Facet Arthroplasty System®(TFAS®) Clinical Trial

Official Title ^ICMJE

A Prospective and Randomized Controlled Trial to Evaluate the Safety and Effectiveness of Total Facet Arthroplasty in the Treatment of Degenerative Spinal Stenosis

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Spinal Stenosis
Low Back Pain
Spondylolisthesis
Lumbar Spinal Stenosis
Leg Pain
Spinal Diseases

Intervention ^ICMJE

Device: Total Facet Arthroplasty System® (TFAS®)

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

450

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years to 85 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

United States

Administrative Information

NCT Number ^ICMJE

NCT00418197

Other Study ID Numbers ^ICMJE

PR0051

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Archus Orthopedics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Archus Orthopedics, Inc.

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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