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Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

NCT00295009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 852

Last updated 2014-08-06

Study results available
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Summary

The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine. There will be separate study arms for one and two level cases.

Conditions

  • Spinal Diseases

Interventions

DEVICE

ProDisc

Total disc replacement with ProDisc

PROCEDURE

Spinal Fusion

A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.

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
2001-09-30
Primary Completion
2011-04-30
Completion
2011-04-30

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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 NCT00295009 on ClinicalTrials.gov