The ProDisc-L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level. Patients receiving the ProDisc-L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the ProDisc-L Total Disc Replacement. |
The ProDisc-L Total Disc Replacement should not be implanted in patients with the following conditions:
Active systemic infection or infection localized to the site of implantation
Osteopenia or osteoporosis defined as DEXA bone density measured T-score < -1.0
Bony lumbar spinal stenosis
Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium)
Isolated radicular compression syndromes, especially due to disc herniation
Pars defect
Involved vertebral endplate that is dimensionally smaller than 34.5 mm in the medial-lateral and/or 27mm in the anterior-posterior directions
Clinically compromised vertebral bodies at the affected level due to current or past trauma
Lytic spondylolisthesis or degenerative spondylolisthesis of grade > 1
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