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Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD

NCT00291018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2017-11-20

Study results available
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Summary

The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).

Conditions

  • Symptomatic Cervical Disc Disease

Interventions

DEVICE

Total Disc Replacement

Total Disc Replacement using ProDisc-C

DEVICE

ACDF

Anterior Cervical Discectomy and Fusion

Sponsors & Collaborators

  • Synthes USA HQ, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-01
Primary Completion
2015-03-01
Completion
2015-03-01

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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 NCT00291018 on ClinicalTrials.gov