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

DePuy Synthes

Status: Completed

Conditions: Cervical Degenerative Disc Disease

Treatments: Device: Cervical TDR; Device: ACDF with plate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432159

06-DISCOVER

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 5 patient groups

1-level Cervical TDR

Experimental group

Description:

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.

Treatment:

Device: Cervical TDR

1-level ACDF with plate

Active Comparator group

Description:

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.

Treatment:

Device: ACDF with plate

2-level Cervical TDR

Experimental group

Description:

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.

Treatment:

Device: Cervical TDR

2-level ACDF

Active Comparator group

Description:

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.

Treatment:

Device: ACDF with plate

Training: 1 & 2-level Cervical TDR

Experimental group

Description:

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.

Treatment:

Device: Cervical TDR