Total Facet Arthroplasty System®(TFAS®) Clinical Trial

Archus Orthopedics

Status and phase

Unknown

Phase 3

Conditions

Lumbar Spinal Stenosis

Leg Pain

Spondylolisthesis

Spinal Stenosis

Spinal Diseases

Low Back Pain

Treatments

Device: Total Facet Arthroplasty System® (TFAS®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00418197

PR0051

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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