Clinical trial NCT00401518: A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Official title: The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis
Lumbar Spinal Stenosis
Facet Arthroplasty
Posterior Fusion
Facet Arthritis
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 390
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;
* Osteoporosis;
* 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 Cobb angle) as indicated by plain X-ray films;
* 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 related to back pain or injury;
* Is a prisoner.

Primary outcomes:
measure: Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score
timeFrame: 24 months
measure: Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score
timeFrame: 24 months
measure: Number of Participants Who Maintained or Improved in Neurological Status.
timeFrame: 24 months
Secondary outcomes:
measure: Mean Visual Analog Scale (VAS) Right Leg Pain
timeFrame: 24 months
measure: Mean Visual Analog Scale (VAS) Left Leg Pain
timeFrame: 24 months
measure: Mean Visual Analog Scale (VAS) Back Pain
timeFrame: 24 months
measure: Number of Participants With a Change of at Least 15 Points in Pain/Disability Using the Oswestry Disability Index (ODI) Score at 24 Months Compared With the Score at Baseline
timeFrame: 24 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Spine Group Beverly Hills
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Spine Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Orthopaedic Center
state: California
city: Boulder
country: United States
facility: Boulder Neurosurgical & Spine Associates
state: Colorado
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: Loveland
country: United States
facility: Rocky Mountain Associates (RMA) in Orthopedic Medicine
state: Colorado
city: Clearwater
country: United States
facility: Florida Spine Institute
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Savannah
country: United States
facility: Neurological Institute of Savannah and Center for Spine
state: Georgia
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopaedics
state: Indiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Owings Mills
country: United States
facility: Rubin Institute for Advanced Orthopaedics
state: Maryland
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Jefferson City
country: United States
facility: Spine Midwest, Inc.
state: Missouri
city: Springfield
country: United States
facility: Springfield Neurological & Spine Institute
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates, P.C.
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Spine Center
state: North Carolina
city: Cincinnati
country: United States
facility: Riverhills Healthcare
state: Ohio
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Brain & Spine
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Bristol
country: United States
facility: Neuro-Spine Solutions
state: Tennessee
city: Chattanooga
country: United States
facility: The Center for Sports Medicine & Orthopedics
state: Tennessee
city: Austin
country: United States
facility: Central Texas Spine Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
References: