Total Facet Arthroplasty System®(TFAS®) Clinical Trial

Tracking Information
First Submitted Date ICMJE	January 2, 2007
First Posted Date ICMJE	January 4, 2007
Last Update Posted Date	February 5, 2009
Study Start Date ICMJE	August 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: January 2, 2007)	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; (submitted: January 2, 2007)	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; (submitted: January 2, 2007)	450
Original Enrollment ICMJE	Same as current
Study 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, Older Adult)
Accepts Healthy Volunteers	No
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