Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
1 other identifier
interventional
500
3 countries
32
Brief Summary
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2006
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 5, 2007
CompletedFirst Posted
Study publicly available on registry
February 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedResults Posted
Study results publicly available
August 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 20, 2017
September 1, 2017
6.8 years
February 5, 2007
May 27, 2014
September 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Success
Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.
24 months
Secondary Outcomes (19)
NDI Success
24 months
Neurological Component of Success
24 months
Subsequent Secondary Surgery Component of Success
24 months
Device-Related SAE Component of Success
24 months
NDI - Change From Baseline
24 months
- +14 more secondary outcomes
Study Arms (5)
1-level Cervical TDR
EXPERIMENTALCervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.
1-level ACDF with plate
ACTIVE COMPARATORAnterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.
2-level Cervical TDR
EXPERIMENTALCervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.
2-level ACDF
ACTIVE COMPARATORAnterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.
Training: 1 & 2-level Cervical TDR
EXPERIMENTALCervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.
Interventions
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Eligibility Criteria
You may qualify if:
- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
- Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
- Moderate Neck Disability Index (NDI) score
- Able to give informed consent for study participation
- Able and willing to return for all follow-up visits
You may not qualify if:
- Significant cervical degenerative disc disease
- Prior fusion procedure at any level(s) (C1-T1)
- Marked cervical instability on lateral or flexion/extension radiographs
- Presence of systemic infection or infection at the surgical site
- Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- History of alcohol and/or drug abuse
- Any known allergy to a metal alloy or polyethylene
- Morbid obesity
- Any significant general illness (e.g., metastatic cancer, HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DePuy Spinelead
Study Sites (32)
Olympia Medical Center
Beverly Hills, California, 90211, United States
Sutter Medical Center
Sacramento, California, 95816, United States
Rocky Mountain Associates in Orthopedic Medicine, PC
Loveland, Colorado, 80538, United States
Yale University
New Haven, Connecticut, 06520, United States
Florida Orthopaedic Institute
Tampa, Florida, 33607, United States
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329, United States
Rush University/Midwest Orthopaedics
Chicago, Illinois, 60607, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611, United States
Johnson County Spine
Overland Park, Kansas, 66210, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Johns Hopkins University
Baltimore, Maryland, 21210, United States
Boston Spine Group
Newton, Massachusetts, 02458, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Twin Cities Spine
Minneapolis, Minnesota, 55404, United States
St. John's Regional Medical Center
Springfield, Missouri, 65804, United States
St. Patrick Hospital Neurological Associates
Missoula, Montana, 59802, United States
Nebraska Spine Center, LLC
Omaha, Nebraska, 68154, United States
Center for Diseases and Surgery of the Spine
Las Vegas, Nevada, 89106, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07101, United States
Southern NY Neurosurgical Group
Johnson City, New York, 13790, United States
Upstate Medical College/SUNY
Syracuse, New York, 13202, United States
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204, United States
Triangle Orthopaedic Associates
Durham, North Carolina, 27704, United States
Neurospine Institute
Eugene, Oregon, 97401, United States
North Texas Spine Care at Baylor Health
Dallas, Texas, 75246, United States
Texas Back Institute
Plano, Texas, 75093, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Pacific Private Clinic
Queensland, 4215, Australia
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment terminated early, and beginning in March 2013, follow-up visits beyond 24 months were limited to Discover subjects only.
Results Point of Contact
- Title
- Lynn Wilson
- Organization
- Depuy Synthes
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2007
First Posted
February 7, 2007
Study Start
July 1, 2006
Primary Completion
May 1, 2013
Study Completion
May 1, 2016
Last Updated
October 20, 2017
Results First Posted
August 7, 2014
Record last verified: 2017-09