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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Lumbar fusion surgery
Silicon Valley Spine Institute
Campbell, California, United States
Conejo Orthopaedic and Spine Institute
Thousand Oaks, California, United States
Improvement in ODI
Time frame: December 2012
Disc Height
Time frame: December 2012
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...and 7 more locations