Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease

Spine Journal

Volumn 9, Issue 4, 2009, Pages 275-286

  Murrey, Daniel ^a   Janssen, Michael ^b   Delamarter, Rick ^c   Goldstein, Jeffrey ^d   Zigler, Jack ^e   Tay, Bobby ^f   Darden, Bruce ^a  

^a ORTHOCAROLINA HIP AND KNEE CENTER   (United States)

^b Spine Education and Research Institute   (United States)

^c SAINT JOHN'S HEALTH CENTER   (United States)

^d NYU HOSPITAL FOR JOINT DISEASES   (United States)

^e TEXAS BACK INSTITUTE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

ACDF; Arthroplasty; Cervical; ProDisc C; Randomized clinical trial; Total disc replacement

Indexed keywords

MUSCLE RELAXANT AGENT; NARCOTIC AGENT;

ADULT; ANTERIOR SPINE FUSION; ARTHROPLASTY; ARTICLE; CERVICAL SPINE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERMETHOD COMPARISON; INTERVERTEBRAL DISK; INTERVERTEBRAL DISKECTOMY; MAJOR CLINICAL STUDY; MALE; NECK PAIN; NEUROLOGIC EXAMINATION; PATIENT SATISFACTION; PHYSICAL ACTIVITY; POSTOPERATIVE PERIOD; PREOPERATIVE EVALUATION; PRIORITY JOURNAL; PROSTHESES AND ORTHOSES; RADIOGRAPHY; RANDOMIZED CONTROLLED TRIAL; REOPERATION; SHORT FORM 36; SPINE DISEASE; VISUAL ANALOG SCALE;

ADULT; ANALGESICS; CERVICAL VERTEBRAE; DEVICE APPROVAL; DISABILITY EVALUATION; DISKECTOMY; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTERVERTEBRAL DISK DISPLACEMENT; MALE; MIDDLE AGED; PATIENT SATISFACTION; POSTOPERATIVE COMPLICATIONS; PROSPECTIVE STUDIES; PROSTHESES AND IMPLANTS; RECOVERY OF FUNCTION; SPINAL FUSION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 62649130630     PISSN: 15299430     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.spinee.2008.05.006     Document Type: Article

References (29)

1. Smith G.W., and Robinson R.A. The treatment of certain cervical spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am 40 (1958) 607-624
2. Cloward R.B. The anterior approach for removal of ruptured cervical discs. J Neurosurg 15 (1958) 602-617
3. Bohlman H.H., Emery S.E., Goodfellow D.B., and Jones P.K. Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy: long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am 75 (1993) 1298-1307
4. Yue W.M., Brodner W., and Highland T.R. Long-term results after anterior cervical discectomy and fusion with allograft and plating: a 5- to 11-year radiologic and clinical follow-up study. Spine 30 (2005) 2138-2144
5. Kaiser M.G., Haid Jr. R.W., Subach B.R., Barnes B., and Rodts Jr. G.E. Anterior cervical plating enhances arthrodesis after discectomy and fusion with cortical allograft. Neurosurgery 50 (2002) 229-238
6. Fraser J.F., and Hartl R. Anterior approaches to fusion of the cervical spine: a meta-analysis of fusion rates. J Neurosurg Spine 6 (2007) 298-303
7. Hilibrand A.S., Carlson G.D., Palumbo M.A., Jones P.K., and Bohlman H.H. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 81 (1999) 519-528
8. Gore D.R., and Sepic S.B. Anterior cervical fusion for degenerated or protruded discs: a review of one hundred forty-six patients. Spine 9 (1984) 667-671
9. Robertson J.T., Papadopoulos S.M., and Traynelis V.C. Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study. J Neurosurg Spine 3 (2005) 417-423
10. Ishihara H., Kanamori M., Kawaguchi Y., Nakamura H., and Kimura T. Adjacent segment disease after anterior cervical interbody fusion. Spine J 4 (2004) 624-628
11. Puttlitz C.M., Rousseau M.A., Xu Z., Hu S., Tay B.K., and Lotz J.C. Intervertebral disc replacement maintains cervical spine kinetics. Spine 29 (2004) 2809-2814
12. DiAngelo D.J., Foley K.T., Morrow B.R., et al. In vitro biomechanics of cervical disc arthroplasty with the ProDisc-C total disc implant. Neurosurg Focus 17 (2004) E7
13. Matsunaga S., Kabayama S., Yamamoto T., Yone K., Sakou T., and Nakanishi K. Strain on intervertebral discs after anterior cervical decompression and fusion. Spine 24 (1999) 670-675
14. Reitman C.A., Hipp J.A., Nguyen L., and Esses S.I. Changes in segmental intervertebral motion adjacent to cervical arthrodesis: a prospective study. Spine 29 (2004) E221-E226
15. Mummaneni P.V., Burkus J.K., Haid R.W., Traynelis V.C., and Zdeblick T.A. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 6 (2007) 198-209
16. Sasso R.C., Smucker J.D., Hacker R.J., and Heller J.G. Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients. Spine 32 (2007 Dec 15) 2933-2940
17. McCormick P.C. Lumbar disc arthroplasty compared with interbody fusion. J Neurosurg Spine 8 (2008) 3-6
18. Glassman S.D., Copay A., Berven S.H., Polly D.W., Suback B.R., and Carreon L.Y. Defining substantial clinical benefit in lumbar spine fusion. Spine J 7 5S (2007) 60S
19. Copay A., Glassman S., Subach B., Berven S., Schuler T., and Carreon L. The minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry disability index, MOS short form-36, and pain scales. Spine J 7 5S (2007) 60S
20. Carragee E., Cheng I., and Wang M. Validation of a "minimum acceptable outcomes" model for outcomes assessment in spinal surgery. Spine J 7 5S (2007) 2S
21. van der Roer N., Ostelo R.W., Bekkering G.E., van Tulder M.W., and de Vet H.C. Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine 31 (2006) 578-582
22. Cleland J.A., Childs J.D., and Whitman J.M. Psychometric properties of the Neck Disability Index and numeric pain rating scale in patients with mechanical neck pain. Arch Phys Med Rehabil 89 (2008) 69-74
23. Pool J.J., Ostelo R.W., Hoving J.L., Bouter L.M., and de Vet H.C. Minimal clinically important change of the Neck Disability Index and the Numerical Rating Scale for patients with neck pain. Spine 32 (2007) 3047-3051
24. Peolsson A. Investigation of clinically important benefit of anterior cervical decompression and fusion. Eur Spine J 16 (2007) 507-514
25. Bertagnoli R., Yue J.J., Pfeiffer F., et al. Early results after ProDisc-C cervical disc replacement. J Neurosurg Spine 2 (2005) 403-410
26. Nabhan A., Ahlhelm F., Shariat K., et al. The ProDisc-C prosthesis: clinical and radiological experience 1 year after surgery. Spine 32 (2007) 1935-1941
27. Vernon H., and Silvano M. The neck disability: a study of reliability and validity. J Manipulative Physiol Ther 14 (1991) 409-415
28. Thomas B.J. . Heterotopic bone formation after total hip arthroplasty. OCNA 23 (1992) 347-358
29. Bryan V.E. Cervical motion segment replacement. Eur Spine J 11 S2 (2002) S92-S97