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Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

NCT ID: NCT00432159

Last Updated: 2017-10-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-01

Study Completion Date

2016-05-01

Brief Summary

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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.

Detailed Description

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This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

Conditions

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Cervical Degenerative Disc Disease

Keywords

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cervical spinal arthroplasty disc surgical ACDF DDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant was masked to which treatment they would receive until AFTER the surgery/treatment procedure. At that point, they were unmasked.

Study Groups

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1-level Cervical TDR

Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.

Group Type EXPERIMENTAL

Cervical TDR

Intervention Type DEVICE

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

1-level ACDF with plate

Anterior 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.

Group Type ACTIVE_COMPARATOR

ACDF with plate

Intervention Type DEVICE

Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.

2-level Cervical TDR

Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.

Group Type EXPERIMENTAL

Cervical TDR

Intervention Type DEVICE

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

2-level ACDF

Anterior 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.

Group Type ACTIVE_COMPARATOR

ACDF with plate

Intervention Type DEVICE

Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.

Training: 1 & 2-level Cervical TDR

Cervical 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.

Group Type EXPERIMENTAL

Cervical TDR

Intervention Type DEVICE

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

Interventions

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Cervical TDR

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

Intervention Type DEVICE

ACDF with plate

Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.

Intervention Type DEVICE

Other Intervention Names

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cervical arthroplasty cervical disc c-TDR DISCOVER disc ACDF Slim-Loc Anterior cervical discectomy and fusion with plate

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Spine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Olympia Medical Center

Beverly Hills, California, United States

Site Status

Sutter Medical Center

Sacramento, California, United States

Site Status

Rocky Mountain Associates in Orthopedic Medicine, PC

Loveland, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Florida Orthopaedic Institute

Tampa, Florida, United States

Site Status

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

Site Status

Rush University/Midwest Orthopaedics

Chicago, Illinois, United States

Site Status

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Johnson County Spine

Overland Park, Kansas, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Boston Spine Group

Newton, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Twin Cities Spine

Minneapolis, Minnesota, United States

Site Status

St. John's Regional Medical Center

Springfield, Missouri, United States

Site Status

St. Patrick Hospital Neurological Associates

Missoula, Montana, United States

Site Status

Nebraska Spine Center, LLC

Omaha, Nebraska, United States

Site Status

Center for Diseases and Surgery of the Spine

Las Vegas, Nevada, United States

Site Status

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, United States

Site Status

Southern NY Neurosurgical Group

Johnson City, New York, United States

Site Status

Upstate Medical College/SUNY

Syracuse, New York, United States

Site Status

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, United States

Site Status

Triangle Orthopaedic Associates

Durham, North Carolina, United States

Site Status

Neurospine Institute

Eugene, Oregon, United States

Site Status

North Texas Spine Care at Baylor Health

Dallas, Texas, United States

Site Status

Texas Back Institute

Plano, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Pacific Private Clinic

Queensland, , Australia

Site Status

St. Elisabeth Ziekenhuis

Tilburg, , Netherlands

Site Status

Countries

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Canada United States Australia Netherlands

Other Identifiers

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06-DISCOVER

Identifier Type: -

Identifier Source: org_study_id