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

Lumbar Spinal Stenosis Clinical Trial

Official title:

The Investigational Plan for the Evaluation of the ACADIA® Facet Replacement System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401518
• Other study ID #: 1020-9052
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: October 2017

Study information

• Verified date: August 2020
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Non-randomized ACADIA® Facet Replacement System
Non-randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
• Randomized ACADIA® Facet Replacement System
Randomized investigational ACADIA Facet Replacement System used for the treatment of lumbar spinal stenosis
• Randomized Instrumented posterolateral fusion (PLF)
Randomized control treatment using an instrumented posterolateral fusion for the treatment of lumbar spinal stenosis

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Albany Medical Center	Albany	New York
United States	Central Texas Spine Institute	Austin	Texas
United States	Spine Group Beverly Hills	Beverly Hills	California
United States	Boulder Neurosurgical & Spine Associates	Boulder	Colorado
United States	Neuro-Spine Solutions	Bristol	Tennessee
United States	Indiana Spine Group	Carmel	Indiana
United States	Charleston Brain & Spine	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolina Neurosurgery and Spine Associates, P.C.	Charlotte	North Carolina
United States	OrthoCarolina Spine Center	Charlotte	North Carolina
United States	The Center for Sports Medicine & Orthopedics	Chattanooga	Tennessee
United States	Riverhills Healthcare	Cincinnati	Ohio
United States	Florida Spine Institute	Clearwater	Florida
United States	Spine Colorado	Durango	Colorado
United States	Fort Wayne Orthopaedics	Fort Wayne	Indiana
United States	Spine Midwest, Inc.	Jefferson City	Missouri
United States	Cedars-Sinai Spine Center	Los Angeles	California
United States	Rocky Mountain Associates (RMA) in Orthopedic Medicine	Loveland	Colorado
United States	Rubin Institute for Advanced Orthopaedics	Owings Mills	Maryland
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Desert Orthopaedic Center	Rancho Mirage	California
United States	University of Utah	Salt Lake City	Utah
United States	Neurological Institute of Savannah and Center for Spine	Savannah	Georgia
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Springfield Neurological & Spine Institute	Springfield	Missouri
United States	Foundation for Orthopaedic Research and Education	Tampa	Florida
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score	Physical Function is measured on a scale of 1-4 points (lower values are considered a better outcome)	24 months
Primary	Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Symptom Severity Score	Symptom Severity is measured on a scale of 1-5 points (lower values are considered a better outcome)	24 months
Primary	Number of Participants Who Maintained or Improved in Neurological Status.	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".	24 months
Secondary	Mean Visual Analog Scale (VAS) Right Leg Pain	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.	24 months
Secondary	Mean Visual Analog Scale (VAS) Left Leg Pain	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.	24 months
Secondary	Mean Visual Analog Scale (VAS) Back Pain	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.	24 months
Secondary	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	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.	24 months