A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
|Lumbar Spinal Stenosis||Device: ACADIA® Facet Replacement System Device: Instrumented posterolateral fusion|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System|
- Improvement in Zurich Claudication Questionnaire Physical Function and Symptom Severity Scores [ Time Frame: 24 months ]
- Lack of device related serious adverse events [ Time Frame: 24 Months ]
- Maintenance or improvement in Neurological status. [ Time Frame: 24 months ]
- No device failures requiring revision, removal, re-operation or supplemental fixation. [ Time Frame: 24 Months ]
- Improvement in pain as measured by Visual Analog Scale [ Time Frame: 24 months ]
- Radiological evidence of fusion in Investigational Group [ Time Frame: 24 months ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Investigational surgical treatment using the ACADIA Facet Replacement system
Device: ACADIA® Facet Replacement System
Investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
Active Comparator: Control Instrumented PLF
Control surgical treatment using an instrumented posterolateral fusion
Device: Instrumented posterolateral fusion
Control treatment using an instrumented posterolateral fusion for the treatment of lumbar 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.
The ACADIA® 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 ACADIA® 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:
- Anatomically based implant design
- Reproducible surgical technique
- Elimination of pain
The ACADIA® 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 those receiving instrumented posterior fusion procedure. Patients will be required to complete study visits before the procedure and at 6 weeks, 3, 6, 12, 24 months post procedure and annually thereafter as required by FDA. Follow up visits consist of administration of questionnaires, radiographs and neurological assessment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401518
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