Indications |
1. Skeletally mature patients |
2. Reconstruction of the disc from C3 to C7 following discectomy |
3. Single or 2 contiguous levels |
4. Intractable radiculopathy (with or without neck pain) or myelopathy (due to abnormality at the level of the disc space) |
5. At least 1 of the following confirmed by imaging (computed tomography, magnetic resonance imaging, or x-rays):
|
6. Failed 6 wk of conservative management or progressive signs or symptoms despite nonoperative treatment |
Contraindications |
1. Acute or chronic infection (systemic or at the operative site) |
2. Osteoporosis or osteopenia (defined as DEXA bone density measured T-score < −2.5 or <1.5, respectively) |
3. Known allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, titanium, hydroxyapatite, or polyethylene) |
4. Compromised vertebral bodies at the index level(s) due to previous trauma to the cervical spine or significant cervical anatomical deformity or disease (eg, ankylosing spondylitis and rheumatoid arthritis) |
5. Marked cervical instability on resting lateral or flexion/extension radiographs (demonstrated by translation <3.5 mm and/or >11° angular difference to that of either level adjacent to the treated level(s)) |
6. Severe facet joint disease or degeneration |
7. Severe spondylosis (defined as bridging osteophytes, loss of disc height >50%, or <2° of motion), as this may lead to limited range of motion and may encourage bone formation (eg, heterotopic ossification and fusion) |
Abbreviation: DEXA, dual-energy x-ray absorptiometry.
a Derived from Summary of Safety and Effectiveness Data for the ProDisc Total Disc Replacement and Mobi-C Cervical Disc Prosthesis.