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NCT00432159 · ClinicalTrials.gov registry record · NA

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

A NA study of Cervical Degenerative Disc Disease, sponsored by DePuy Spine.

Completed
Registry status
NA
Development phase
500
Enrollment target
20
Study locations

NCT00432159: Completed NA study of Cervical Degenerative Disc Disease, sponsored by DePuy Spine.

NCT00432159 is a NA study of Cervical Degenerative Disc Disease that has completed, run by DePuy Spine. The registered enrollment target is 500 participants, above the 169-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (196% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00432159, a NA study of Cervical Degenerative Disc Disease, has completed, sponsored by DePuy Spine.

COMPLETED
Registry status
NA
Development phase
500 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

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.

Conditions Studied

Cervical Degenerative Disc Disease

Interventions

  • DEVICE Cervical TDR
  • DEVICE ACDF with plate

Study Locations (20)

Michigan

  • University of Michigan - Ann Arbor
  • Borgess Medical Center - Kalamazoo
  • William Beaumont Hospital - Royal Oak

California

  • Olympia Medical Center - Beverly Hills
  • Sutter Medical Center - Sacramento

Illinois

  • Rush University/Midwest Orthopaedics - Chicago
  • Northwestern Medical Faculty Foundation - Chicago

Colorado

  • Rocky Mountain Associates in Orthopedic Medicine, PC - Loveland

Connecticut

  • Yale University - New Haven

Florida

  • Florida Orthopaedic Institute - Tampa

Georgia

  • Emory Orthopaedics and Spine Center - Atlanta

Kansas

  • Johnson County Spine - Overland Park

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2006-07-01
Est. Completion 2016-05-01
Phase NA
DePuy Spine

5 total trials

What the finished NCT00432159 record still lists

NCT00432159 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (196% higher).

The record links to 1 condition, with Cervical Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Cervical TDR is the first listed.

NCT00432159 names 20 study sites across 16 states, led by Michigan, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00432159 about?

NCT00432159 is a clinical study titled "Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)". 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 pos...

What is the current status of trial NCT00432159?

This trial is currently completed. It is a NA study. The enrollment target is 500 participants. The study started on 2006-07-01. Estimated completion is 2016-05-01.

What conditions does trial NCT00432159 study?

This clinical trial studies the following conditions: Cervical Degenerative Disc Disease.

What interventions are being tested in trial NCT00432159?

The interventions under investigation include: Cervical TDR (DEVICE), ACDF with plate (DEVICE).

Who is sponsoring clinical trial NCT00432159?

This trial is sponsored by DePuy Spine, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00432159 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00432159, the US trial registry maintained by the National Library of Medicine. NCT00432159 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.