CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 852 enrolled
Drug / intervention
ProDisc +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00295009
NCT00295009N/ACompleted
CompareCT.gov

A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated With DDD in the Lumbosacral Spine

Synthes USA HQ, Inc.·interventional·Posted Feb 22, 2006·Updated Aug 6, 2014

In Brief

A clinical study evaluating ProDisc and Spinal Fusion for Spinal Diseases. Completed, enrolled 852 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Diseases
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2006
Enrollment StartSep 1, 2001
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 20.4 years ago

Interventions

ProDiscdevice

Total disc replacement with ProDisc

Spinal Fusionprocedure

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.