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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Globus Medical Inc
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc
ClinicalTrials.gov Identifier:
NCT00401518
First received: November 17, 2006
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Lumbar Spinal Stenosis
Device: ACADIA® Facet Replacement System
Device: Instrumented posterolateral fusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System

Resource links provided by NLM:


Further study details as provided by Globus Medical Inc:

Primary Outcome Measures:
  • Improvement in Zurich Claudication Questionnaire Physical Function and Symptom Severity Scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Lack of device related serious adverse events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • Maintenance or improvement in Neurological status. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • No device failures requiring revision, removal, re-operation or supplemental fixation. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in pain as measured by Visual Analog Scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Radiological evidence of fusion in Investigational Group [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: October 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACADIA®
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

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

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401518

Contacts
Contact: Jacqueline Myer 610-930-1800 ext 1669 jmyer@globusmedical.com

  Show 29 Study Locations
Sponsors and Collaborators
Globus Medical Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT00401518     History of Changes
Other Study ID Numbers: 1020-9052
Study First Received: November 17, 2006
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Globus Medical Inc:
Spinal Stenosis
Lumbar Spinal Stenosis
Facet Arthroplasty
Posterior Fusion
Facet Arthritis

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014