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

First Received on January 2, 2007. Last Updated on February 4, 2009 History of Changes

Sponsor:	Archus Orthopedics, Inc.
Information provided by:	Archus Orthopedics, Inc.
ClinicalTrials.gov Identifier:	NCT00418197

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 III

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:

MedlinePlus related topics: Back Pain Spinal Stenosis Spine Injuries and Disorders

U.S. FDA Resources

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

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
Constriction, Pathologic
Low Back Pain
Spinal Diseases
Spinal Stenosis
Spondylolisthesis
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on February 09, 2012