A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Alexander Mason, MD; Sharad Rajpal, MD; Kara Beasley, DO
Sponsor: Globus Medical Inc.
The purpose of this study is to determine if the ACADIA® 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.
Primary Outcome Measures
- Improvement in Zurich Claudication Questionnaire Physical Function and Symptom Severity Scores.
- Lack of device related serious adverse events.
- Maintenance or improvement in Neurological status.
- No device failures requiring revision, removal, re-operation or supplemental fixation.
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 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 AFRS™ 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.
- 21-85 years of age and skeletally mature;
- Have undergone 6 months of non-operative treatment prior to surgery;
- Lateral, lateral recess and/or central canal stenosis;
- Disc height measuring = 4 mm at the operative level;
- Persistent leg, thigh and/or buttock symptoms, including pain, numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;
- A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate;
- A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score;
- A candidate for a decompression with full facetectomy at the operative level;
- Candidate for a posterior lumbar fusion;
- Physically and mentally willing and able to comply evaluations;
- Lives in the immediate area and has no plans to relocate;
- Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;
- Previous lumbar fusion or disc replacement procedure;
- Greater than Grade I spondylolisthesis or retrolisthesis;
- Spondylolisthesis at levels other than at the operative level;
- Scoliosis of the lumbar spine (defined as more than 11 deg sagittal deformity);
- Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease;
- Acute traumatic pars fracture at the operative/adjacent level vertebral body;
- Spinal stenosis at more than three lumbar segments;
- Acute trauma to the lumbar spine within the last 24 months;
- Active infection at the operative level, or a systemic infection;
- Physically / mentally compromised;
- Systemic disease that would affect the patient's welfare or the research study;
- Immunologically suppressed or immunocompromised;
- Insulin-Dependent Diabetes Mellitus (Type I Diabetes);
- Currently undergoing long-term steroid therapy;
- Metabolic bone disease;
- Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years;
- Known allergy to cobalt chromium or titanium;
- Used any investigational drug or device within the past 30 days;
- Pending litigation or receiving Workers Compensation related to back pain or injury;
- Is a prisoner;
The lumbar spine is made up of five vertebrae (bones) in your lower back, separated by spinal discs and linked by facet joints. The vertebrae protect the spinal cord (bundle of nerves) as it runs through the spinal canal. The discs help absorb pressure and distribute stress between the vertebrae. The facet joints help make the spine flexible and stable. As you age, your facet joints may break down and degenerate. When facet joints degenerate, bone spurs may form around your spine. Sometimes bone spurs form at the edges of the facet joints where nerve roots leave the spinal canal, which narrows the area around the spinal cord. This narrowing is called lumbar spinal stenosis. When bone spurs rub against a nerve root, the nerve can become irritated and inflamed. This may cause pain, numbness, tingling, and weakness in the lower back, buttocks, and legs. These symptoms may be worse when standing or bending backwards and may be relieved when sitting or bending forward.
The main goal of surgery to treat lumbar spinal stenosis is decompression (freeing the nerves and nerve roots from compressing structures). If too much of these structures need to be removed to free the nerve, the spine may become unstable and may require a fusion. The objective of fusion surgery is to relieve pressure on the nerves and prevent motion at a spinal segment by permanently fusing two or more vertebrae together. The spine is fused by implanting screws and rods that act to hold a spinal segment rigid. This procedure may help to reduce or eliminate painful symptoms but it has potential disadvantages, including loss of motion. An alternative treatment that does not require fusion after decompressing the spine may provide a significant patient benefit.
The ACADIA® Facet Replacement System is designed to allow motion after removing the degenerated facet joints and other structures that are compressing the nerves and nerve roots. ACADIA® is implanted using a posterior approach (from the back) to the lumbar spine. Specialized tools are used to implant the articulating (moving together) implants. The implants are aligned and secured in a position that mimics the natural facet joints in the lumbar spine. After surgery, the system is designed to move and slide to allow motion in the spinal segment.