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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00401518
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Tracking Information
First Submitted Date  ICMJE November 17, 2006
First Posted Date  ICMJE November 20, 2006
Results First Submitted Date  ICMJE August 10, 2020
Results First Posted Date  ICMJE September 10, 2020
Last Update Posted Date September 10, 2020
Study Start Date  ICMJE October 2006
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score [ Time Frame: 24 months ]
    Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)
  • Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score [ Time Frame: 24 months ]
    Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)
  • Number of Participants Who Maintained or Improved in Neurological Status. [ Time Frame: 24 months ]
    Neurological status is based on four types of measurement parameters: muscle strength, straight leg raise, sensory function, and reflexes. Each of the four parameters will be coded as Stable or Improved OR Deteriorated. Neurological assessment scores must be stable or improved compared with the preoperative baseline to be considered "Stable or Improved" neurological status. If these scores have deteriorated as compared to the preoperative baseline, then the neurological status is considered "Deteriorated".
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2006)
  • Improvement in disability
  • Lack of procedure related adverse events
  • Neurological status.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Mean Visual Analog Scale (VAS) Right Leg Pain [ Time Frame: 24 months ]
    The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
  • Mean Visual Analog Scale (VAS) Left Leg Pain [ Time Frame: 24 months ]
    The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
  • Mean Visual Analog Scale (VAS) Back Pain [ Time Frame: 24 months ]
    The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with "no pain" on the left border and "as severe as it could be" on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.
  • 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 [ Time Frame: 24 months ]
    The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2006)
  • Improvement in pain
  • Radiological status
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
Official Title  ICMJE The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spinal Stenosis
Intervention  ICMJE
  • Device: Non-randomized ACADIA® Facet Replacement System
    Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
  • Device: Randomized ACADIA® Facet Replacement System
    Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
  • Device: Randomized Instrumented posterolateral fusion (PLF)
    Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis
Study Arms  ICMJE
  • Experimental: ACADIA®
    Investigational surgical treatment using the ACADIA Facet Replacement system
    Interventions:
    • Device: Non-randomized ACADIA® Facet Replacement System
    • Device: Randomized ACADIA® Facet Replacement System
  • Active Comparator: Control Instrumented PLF
    Control surgical treatment using an instrumented posterolateral fusion
    Intervention: Device: Randomized Instrumented posterolateral fusion (PLF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2015)
390
Original Enrollment  ICMJE
 (submitted: November 17, 2006)
300
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401518
Other Study ID Numbers  ICMJE 1020-9052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Globus Medical Inc
Study Sponsor  ICMJE Globus Medical Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Globus Medical Inc
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP