Overview

This trial is active, not recruiting.

Condition cervical degenerative disc disease
Treatments cervical tdr, acdf with plate
Sponsor DePuy Spine
Start date July 2006
End date May 2013
Trial size 500 participants
Trial identifier NCT00432159, 06-DISCOVER

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cervical tdr cervical arthroplasty
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
(Active Comparator)
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.
acdf with plate ACDF
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
(Experimental)
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.
cervical tdr cervical arthroplasty
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
(Active Comparator)
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.
acdf with plate ACDF
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
(Experimental)
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.
cervical tdr cervical arthroplasty
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

Primary Outcomes

Measure
Overall Success
time frame: 24 months

Secondary Outcomes

Measure
NDI Success
time frame: 24 months
Neurological Component of Success
time frame: 24 months
Subsequent Secondary Surgery Component of Success
time frame: 24 months
Device-Related SAE Component of Success
time frame: 24 months
NDI - Change From Baseline
time frame: 24 months
Neck Pain VAS Scores - Change From Baseline
time frame: 24 months
Maximum Arm Pain VAS - Change From Baseline
time frame: 24 months
Average Arm Pain VAS - Change From Baseline
time frame: 24 months
Maximum Shoulder Pain VAS - Change From Baseline
time frame: 24 months
Average Shoulder Pain VAS - Change From Baseline
time frame: 24 months
Dysphagia Disability Index - Change From Baseline
time frame: 24 months
SF-36 - Physical Composite Scores (PCS) - Change From Baseline
time frame: 24 months
SF-36 - Mental Composite Scores (MCS) - Change From Baseline
time frame: 24 months
Work Status Assessment
time frame: 24 months
Return to Work
time frame: 24 months
Activity
time frame: 24 months
Subject Satisfaction
time frame: 24 months
Global Cervical Range of Motion - Change From Baseline
time frame: 24 months
Average Radiographic Disc Height (mm) - Change From Post-op
time frame: 24 months

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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)

Additional Information

Official title A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by DePuy Spine.