Table 2

Indications and Contraindications for ProDisc-L.

Indications for UseContraindications
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