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XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD) — XL TDR  

Degenerative Disc Disease Clinical Trial

Official title:
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

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.

Clinical Trial Description

The XL TDR® eXtreme Lateral Total Disc Replacement consists of two endplates that are provided in a number of sizes to accommodate a variety of patient anatomies and pathologies. The XL TDR device is made up of a ball and socket articulation and the joint is made of CoCrMo alloy.

The XL TDR is intended to be used to reconstruct the spine following the removal of part or all of the intervertebral disc on one level of the lumbar spine.

The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00927238
Study type Interventional
Source NuVasive
Contact
Status Completed
Phase Phase 3
Start date July 2009
Completion date July 2015
View Details
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