NuVasive, Inc announced that it will be completing the study of Lateral Lumbar TDR by December 2012.
Lateral Lumbar TDR(LTDR) is a total disc replacement system which will restore and maintain the normal range of motion and the sagittal balance of the spine.
The purpose of this study is to evaluate the safety and effectiveness of LTDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications. This comparison will be done by demonstrating non-inferior results at the 24-month follow up period pertaining to improvement in the Oswestry Disability Index (ODI), maintenance or improvement in neurological status, complication rate and revision, re-operation, removal rate.
The 300 patient study is not yet open for participant recruitment. The official title of the study is “A Pivotal, Multi-Center, Clinical Trial Evaluating The Safety And Effectiveness of The Lumbar TDR Device In Patients With Single-Level Lumbar Degenerative Disc Disease”.