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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

NCT00667459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2023-06-06

Study results available
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Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Conditions

  • Cervical Degenerative Disc Disease

Interventions

DEVICE

PRESTIGE® LP Cervical Disc

The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.

DEVICE

ATLANTIS Anterior Cervical Plate

Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-01-31
Completion
2014-06-30

Countries

  • United States

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 NCT00667459 on ClinicalTrials.gov