A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

NCT ID: NCT00401518

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ACADIA®

Investigational surgical treatment using the ACADIA Facet Replacement system

Group Type: EXPERIMENTAL

Non-randomized ACADIA® Facet Replacement System

Intervention Type: DEVICE

Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

Randomized ACADIA® Facet Replacement System

Intervention Type: DEVICE

Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

Control Instrumented PLF

Control surgical treatment using an instrumented posterolateral fusion

Group Type: ACTIVE_COMPARATOR

Randomized Instrumented posterolateral fusion (PLF)

Intervention Type: DEVICE

Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Interventions

Non-randomized ACADIA® Facet Replacement System

Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

Intervention Type: DEVICE

Randomized ACADIA® Facet Replacement System

Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis

Intervention Type: DEVICE

Randomized Instrumented posterolateral fusion (PLF)

Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Globus Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Spine Group Beverly Hills

Beverly Hills, California, United States

Cedars-Sinai Spine Center

Los Angeles, California, United States

Desert Orthopaedic Center

Rancho Mirage, California, United States

Boulder Neurosurgical & Spine Associates

Boulder, Colorado, United States

Spine Colorado

Durango, Colorado, United States

Rocky Mountain Associates (RMA) in Orthopedic Medicine

Loveland, Colorado, United States

Florida Spine Institute

Clearwater, Florida, United States

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Neurological Institute of Savannah and Center for Spine

Savannah, Georgia, United States

Indiana Spine Group

Carmel, Indiana, United States

Fort Wayne Orthopaedics

Fort Wayne, Indiana, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Rubin Institute for Advanced Orthopaedics

Owings Mills, Maryland, United States

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

Spine Midwest, Inc.

Jefferson City, Missouri, United States

Springfield Neurological & Spine Institute

Springfield, Missouri, United States

Albany Medical Center

Albany, New York, United States

Carolina Neurosurgery and Spine Associates, P.C.

Charlotte, North Carolina, United States

OrthoCarolina Spine Center

Charlotte, North Carolina, United States

Riverhills Healthcare

Cincinnati, Ohio, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Charleston Brain & Spine

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Neuro-Spine Solutions

Bristol, Tennessee, United States

The Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, United States

Central Texas Spine Institute

Austin, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1020-9052

Identifier Type: -

Identifier Source: org_study_id