AFRS™: Anatomic Facet Replacement System Clinical Study

This study is currently NOT recruiting participants.
Verified by Facet Solutions, Inc. January 2008

Sponsored by: Facet Solutions, Inc.
Information provided by: Facet Solutions, Inc.
ClinicalTrials.gov Identifier: NCT00401518

Official Website: www.stenosisrelief.com

clinical trials Purpose

The purpose of this study is to determine if the Anatomic Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

Condition Intervention Phase
Spinal Stenosis Device: Facet Arthroplasty Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Evaluation of the Anatomic Facet Replacement System to Treat Spinal Stenosis

Primary Outcome Measures:
1. Improvement in disability
2. Lack of procedure related adverse events
3. Neurological status.

Secondary Outcome Measures:
1. Improvement in pain
2. Radiological status

Further study details as provided by Facet Solutions, Inc.:

Total Enrollment: 300

Study start: November 2006; Expected completion: November 2009

About Spinal Stenosis:
Spinal Stenosis continues to be a major cause of back and leg pain. The condition is attributed to narrowing of the space around the nerves in the lumbar spine. This is often caused by the degenerative process in the spine and the facet joints. The current treatment calls for removal of bone around the affected nerve including the facet joints and fusing the posterior of the spine to ensure the segments remain stable.

About the Anatomic Facet Replacement System (AFRS™):
The Anatomic Facet Replacement System (AFRS™) allows for an anatomic reconstruction of the facet joint after decompression and removal of the degenerated facet. Like the original facet joint, the replacement implant is designed to reproduce facet motion while restoring normal stability and motion.

The Anatomic Facet Replacement System (AFRS™) has been designed on the principals that have allowed other total joint replacement procedures to provide significant patient benefits.

These guiding principals include:
1. Anatomically based implant design
2.Reproducible surgical technique
3.Elimination of pain The Anatomic Facet Replacement System allows the surgeon to remove the offending bone while preserving the motion of the facet joint.

This study will evaluate the outcomes of patients using the AFRS investigation compared to the current posterior fusion procedure. Patients will be required to complete study visits before the procedure and at 6 weeks, 3, 6, 12 and 24 months post procedure. Follow up visits consist of administration of questionnaires, radiographs and neurological assessment.

clinical trials Eligibility

Ages Eligible for Study: 21 Years - 75 Years
Genders Eligible for Study:
Both Accepts Healthy Volunteers

Criteria

Inclusion Criteria:
1. 21-75 years of age and skeletally mature.
2. Have undergone 6 months of non-operative treatment prior to surgery.
3. Lateral, lateral recess and/or central canal stenosis
4. Disc height is at least half of either adjacent level
5. Greater leg pain than back pain
6. A minimum score of 40 on the Oswestry Disability Index.
7. Candidate for a decompression and full facetectomy.
8. Candidate for a posterior lumbar fusion.
9. Physically and mentally willing and able to comply evaluations.

Exclusion Criteria:
1. Active infection or pending treatment for HIV or Hepatitis C.
2. Two or more previous surgical procedures at the operative level
3. Osteoporosis
4. Greater than Grade I spondylolisthesis
5. Pars fracture at the operative or adjacent level
6. Spinal stenosis of three or more lumbar segments
7. Trauma to the lumbar spine
8. Physically or mentally compromised
9. Diagnosed systemic disease
10. Metabolic bone disease
11. Spondylolisthesis at levels other than the operative level
12. Scoliosis of the lumbar spine
13. Pregnant or interested in becoming pregnant
14. Medically significant obesity
16. Known allergy to cobalt chromium..
17. Use of any investigational drug or device within the past 30 days.
18. Pending litigation related to back pain or injury.

clinical trialsLocations

This study is currently NOT recruiting participants.

clinical trials More Information

To learn more, visit: www.stenosisrelief.com

Study ID Numbers: 1020-9052
Last Updated: January 29, 2007
Record first received: November 17, 2006
ClinicalTrials.gov Identifier: NCT00401518
Health Authority: United States: Food and Drug Administration

Last Updated: 01/30/2008
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