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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 October 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: October 16, 2014
Last verified: October 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: 450
Study Start Date: October 2006
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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

  Hide Study Locations
Locations
United States, California
Spine Group Beverly Hills Recruiting
Beverly Hills, California, United States, 90211
Contact: Nicole Blackwell    310-881-3730    nicole@spinegroupbeverlyhills.com   
Principal Investigator: John Regan, MD         
Cedars-Sinai Spine Center Recruiting
Los Angeles, California, United States, 90048
Contact: Cecilia Bruce    310-423-9779    Cecilia.Bruce@cshs.org   
Principal Investigator: Neel Anand, MD         
Desert Orthopaedic Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Charlie Cyr    760-766-1207    ccyr@desertortho.com   
Principal Investigator: A. David Tahernia, MD         
Sub-Investigator: Reginald Fayssoux, MD         
United States, Colorado
Boulder Neurosurgical & Spine Associates Recruiting
Boulder, Colorado, United States, 80303
Contact: Sigita Burneikiene, MD    303-938-5700    sigitab@bnasurg.com   
Principal Investigator: Alan Villavicencio, MD         
Sub-Investigator: E. Lee Nelson, MD         
Sub-Investigator: Sharad Rajpal, MD         
Sub-Investigator: Kara Beasley, DO         
Sub-Investigator: Alexander Mason, MD         
Sub-Investigator: David Shafer, MD         
Spine Colorado Recruiting
Durango, Colorado, United States, 81301
Contact: Rachel Ebner    970-375-3696    REbner@dgoortho.org   
Contact: Sue Lynn Myhre, PhD    970-375-3697    SMyhre@spinecolorado.com   
Principal Investigator: Jim Youssef, MD         
Sub-Investigator: Douglas Orndorff, MD         
Rocky Mountain Associates (RMA) in Orthopedic Medicine Recruiting
Loveland, Colorado, United States, 80538
Contact: Kira Sniff    970-669-8881    ksniff@rmaortho.com   
Principal Investigator: Kenneth Pettine, MD         
United States, Florida
Florida Spine Institute Recruiting
Clearwater, Florida, United States, 33765
Contact: Rose Bingham, RN    727-724-5673    rbingham@floridaspineinstitute.com   
Principal Investigator: Scott Webb, DO         
Sub-Investigator: John Drygas, MD         
Foundation for Orthopaedic Research and Education Recruiting
Tampa, Florida, United States, 33637
Contact: Debbi Warren, RN, CCRC    813-978-9700 ext 6766    Deborah.Warren@foreonline.org   
Principal Investigator: John Small, MD         
Sub-Investigator: Farhan Siddiqi, MD         
Sub-Investigator: James Billys, MD         
United States, Georgia
Neurological Institute of Savannah and Center for Spine Recruiting
Savannah, Georgia, United States, 31405
Contact: Victoria Taylor, RN    912-350-8568    taylovi2@memorialhealth.com   
Principal Investigator: James Lindley, MD         
United States, Indiana
Fort Wayne Orthopaedics Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Kary Stout, CCRC, MBA    260-436-6589 ext 4278    kstout@fwortho.com   
Principal Investigator: Kevin Rahn, MD         
Sub-Investigator: Robert Shugart, MD         
Sub-Investigator: Michael Arata, MD         
United States, Louisiana
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Marcus Stone, PhD    318-629-5585    mstone@louisianaspine.org   
Principal Investigator: Pierce Nunley, MD         
Sub-Investigator: Andrew Utter, MD         
Sub-Investigator: David Cavanaugh, MD         
United States, Maryland
Rubin Institute for Advanced Orthopaedics Recruiting
Owings Mills, Maryland, United States, 21117
Contact: Barbara McCann    410-469-4410    bmccann@lifebridgehealth.org   
Principal Investigator: Charles Hartjen, MD         
United States, Massachusetts
UMASS Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
Principal Investigator: Patrick Connolly, MD         
Sub-Investigator: Anthony Lapinsky, MD         
United States, Missouri
Spine Midwest, Inc. Recruiting
Jefferson City, Missouri, United States, 65101
Contact: Jane Bedsworth, RN    573-636-9000 ext 322    Jane@SpineMidwest.com   
Principal Investigator: William Rodgers, MD         
Springfield Neurological & Spine Institute Recruiting
Springfield, Missouri, United States, 65804
Contact: Jessica Ratcliff    417-885-3888 ext 1214    jratcliff@springfieldneurological.com   
Principal Investigator: Chad Morgan, MD         
Sub-Investigator: Thomas Briggs, MD         
Sub-Investigator: Wade Ceola, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Linda Graca, LPN    518-262-5868    gracal@mail.amc.edu   
Contact: Barbara Smith, RN    518-262-2078    smithb1@mail.amc.edu   
Principal Investigator: Darryl DiRisio, MD         
United States, North Carolina
Carolina Neurosurgery and Spine Associates, P.C. Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Susan Lydon, RN    704-831-4010    susan.lydon@CNSA.com   
Contact: Peggy Boltes, RN    704-831-4006    peggy.boltes@cnsa.com   
Principal Investigator: Domagoj Coric, MD         
Sub-Investigator: Paul Kim, MD         
Sub-Investigator: Kevin Cahill, MD         
OrthoCarolina Spine Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Barbara Ann Rice    704-323-2264    babara.rice@orthocarolina.com   
Principal Investigator: Alfred Rhyne, MD         
United States, Ohio
Riverhills Healthcare Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Nancy Firsich, RN, BSN, CCRC    513-865-1148    nancy_firsich@trihealth.com   
Contact: Sue Dorroh, RN    513-865-1148    Susan_Dorroh@trihealth.com   
Principal Investigator: Jonathan A. Borden, MD         
Sub-Investigator: Gregory A. Howes, DO         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Barbara Finn    215-830-8700 ext 3121    bfinn@paortho.com   
Principal Investigator: Victor Hsu, MD         
Sub-Investigator: Michael Gratch, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Diane Cantella, RN, CCRN    412-359-3353    dcantell@wpahs.org   
Contact: Dorothy Packer, RN    412-359-6505    dpacker@wpahs.org   
Principal Investigator: Donald Whiting, MD         
Sub-Investigator: E. Richard Prostko, MD         
Sub-Investigator: Michael Oh, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Laura Fields    843-792-3131    fiela@musc.edu   
Contact: Clare Tyson    843-792-1534    tysonc@musc.edu   
Principal Investigator: Barton L. Sachs, MD         
Sub-Investigator: John Glaser, MD         
Charleston Brain & Spine Recruiting
Charleston, South Carolina, United States, 29406
Contact: Laurie James    843-553-7615    laurie@charlestonbrainandspine.com   
Principal Investigator: Jason Highsmith, MD         
Sub-Investigator: Mike Tyler, MD         
United States, Tennessee
Neuro-Spine Solutions Recruiting
Bristol, Tennessee, United States, 37620
Contact: Renee Stiltner    423-844-0501    research@neurospinesolutions.net   
Principal Investigator: Morgon Lorio, MD         
The Center for Sports Medicine & Orthopedics Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Danette Newton    423-624-2696    danette_newton@yahoo.com   
Contact: Renee Chambers       rchambers@sportmed.com   
Principal Investigator: Scott Hodges, DO         
United States, Texas
Central Texas Spine Institute Recruiting
Austin, Texas, United States, 78731
Contact: Amy Sasser    512-374-0677    asasser@pqrinc.com   
Principal Investigator: Randall Dryer, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Ashley Neese    801-587-5430    ashley.neese@hsc.utah.edu   
Principal Investigator: Darrel Brodke, MD         
Sub-Investigator: Brandon Lawrence, MD         
Sub-Investigator: William R. Spiker, MD         
Puerto Rico
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00921
Contact: Lhyell Baerga    787-777-3535 ext 6220    lhyellbc@gmail.com   
Principal Investigator: Enrique Escobar, MD         
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: October 16, 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
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014