NCT00401518

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
2 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 10, 2020

Completed
Last Updated

September 10, 2020

Status Verified

August 1, 2020

Enrollment Period

10.8 years

First QC Date

November 17, 2006

Results QC Date

August 10, 2020

Last Update Submit

August 24, 2020

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal StenosisLumbar Spinal StenosisFacet ArthroplastyPosterior FusionFacet Arthritis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Mean Visual Analog Scale (VAS) Right Leg Pain

    24 months

  • Mean Visual Analog Scale (VAS) Left Leg Pain

    24 months

  • Mean Visual Analog Scale (VAS) Back Pain

    24 months

  • 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

    24 months

Study Arms (2)

ACADIA®

EXPERIMENTAL

Investigational surgical treatment using the ACADIA Facet Replacement system

Device: Non-randomized ACADIA® Facet Replacement SystemDevice: Randomized ACADIA® Facet Replacement System

Control Instrumented PLF

ACTIVE COMPARATOR

Control surgical treatment using an instrumented posterolateral fusion

Device: Randomized Instrumented posterolateral fusion (PLF)

Interventions

Non-randomized ACADIA® Facet Replacement SystemDEVICE

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

ACADIA®
Randomized ACADIA® Facet Replacement SystemDEVICE

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

ACADIA®
Randomized Instrumented posterolateral fusion (PLF)DEVICE

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

Control Instrumented PLF

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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);
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Spine Group Beverly Hills

Beverly Hills, California, 90211, United States

Location

Cedars-Sinai Spine Center

Los Angeles, California, 90048, United States

Location

Desert Orthopaedic Center

Rancho Mirage, California, 92270, United States

Location

Boulder Neurosurgical & Spine Associates

Boulder, Colorado, 80303, United States

Location

Spine Colorado

Durango, Colorado, 81301, United States

Location

Rocky Mountain Associates (RMA) in Orthopedic Medicine

Loveland, Colorado, 80538, United States

Location

Florida Spine Institute

Clearwater, Florida, 33765, United States

Location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Neurological Institute of Savannah and Center for Spine

Savannah, Georgia, 31405, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Rubin Institute for Advanced Orthopaedics

Owings Mills, Maryland, 21117, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Spine Midwest, Inc.

Jefferson City, Missouri, 65101, United States

Location

Springfield Neurological & Spine Institute

Springfield, Missouri, 65804, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Carolina Neurosurgery and Spine Associates, P.C.

Charlotte, North Carolina, 28204, United States

Location

OrthoCarolina Spine Center

Charlotte, North Carolina, 28207, United States

Location

Riverhills Healthcare

Cincinnati, Ohio, 45242, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Charleston Brain & Spine

Charleston, South Carolina, 29406, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Neuro-Spine Solutions

Bristol, Tennessee, 37620, United States

Location

The Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, 37404, United States

Location

Central Texas Spine Institute

Austin, Texas, 78731, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Puerto Rico

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
Director of Clinical Affairs
Organization
Globus Medical
jmyer@globusmedical.com
610-930-1800

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

September 10, 2020

Results First Posted

September 10, 2020

Record last verified: 2020-08

Locations

PR(1)US(28)