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

NCT00432159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2017-10-20

Study results available
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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.

Conditions

  • Cervical Degenerative Disc Disease

Interventions

DEVICE

Cervical TDR

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

DEVICE

ACDF with plate

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

Sponsors & Collaborators

  • DePuy Spine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-01
Primary Completion
2013-05-01
Completion
2016-05-01
FDA Device
Yes

Countries

  • United States
  • Australia
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432159 on ClinicalTrials.gov