Overview

This trial has been completed.

Condition lumbar degenerative disc disease
Treatment triumph® lumbar artificial disc
Sponsor Globus Medical Inc
Start date September 2010
End date December 2016
Trial size 20 participants
Trial identifier NCT01198470, G090143

Summary

The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).
triumph® lumbar artificial disc
The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.

Primary Outcomes

Measure
ODI score
time frame: 24 months

Eligibility Criteria

All participants from 18 years up to 65 years old.

Inclusion Criteria: - Degenerative Disc Disease in one vertebral level between L1 and S1 - Able to understand and sign informed consent - Had at least 6 months of conservative treatment - Oswestry Disability Index Score of at least 30 (one a 100 point scale) - Other inclusion criteria as specified in approved IDE protocol Exclusion Criteria: - Bilateral leg pain - Back or leg pain of unknown etiology - Prior fusion surgery or another spinal device implanted at any other lumbar level - Osteoporosis or osteopenia - Other exclusion criteria as specified in approved IDE protocol

Additional Information

Official title A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Globus Medical Inc.