Point of view: Commentary on the research reports that led to food and drug administration approval of an artificial disc

Spine

Volumn 30, Issue 14, 2005, Pages 1561-1564

  Mirza, Sohail K ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NARCOTIC AGENT;

ANALGESIA; ANTERIOR SPINE FUSION; ARTHROPLASTY; ARTIFICIAL INTERVERTEBRAL DISK; BONE PROSTHESIS; CLINICAL TRIAL; DEVICE; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERVERTEBRAL DISK; INTERVERTEBRAL DISK DEGENERATION; MEDICAL RESEARCH; META ANALYSIS; POSTOPERATIVE COMPLICATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SPINE MOBILITY; SPINE SURGERY; SURGICAL TECHNIQUE; SYSTEMATIC REVIEW; TREATMENT INDICATION; TREATMENT OUTCOME;

CLINICAL TRIALS; EQUIPMENT SAFETY; HUMANS; INTERVERTEBRAL DISK; PROSTHESES AND IMPLANTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 22544463971     PISSN: 03622436     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.brs.0000171806.30401.40     Document Type: Editorial

References (18)

1. DePuy Spine, Inc. Charite artificial disc. Natural motion is back. An alternative to lumbar spinal fusion surgery. Available at: http://www. charitedisc.com/. Accessed May 12, 2005.
2. Boden SD, Balderston RA, Heller JG, et al. An AOA critical issue. Disc replacements: this time will we really cure low-back and neck pain? J Bone Joint Surg Am 2004;86-A:411-22.
3. Singh K, Vaccaro AR, Albert TJ. Assessing the potential impact of total disc arthroplasty on surgeon practice patterns in North America. Spine J 2004; 4:195S-201S.
4. Callaghan JJ, Crowninshieid RD, Greenwald AS, et al. Symposium: Introducing technology into orthopaedic practice. How should it be done? J Bone Joint Surg Am 2005;87:1146-58.
5. Tillman D-B (Director, Office of Device Evaluation, Center of Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration) in the approval order dated October 26, 2004, addressed to Mr. William Chrisrianson, Vice President, Clinical and Regulatory Affairs, Depuy Spine, Inc. Available at: http://www.fda.gov/cdrh/pdf4/P040006a.pdf. Accessed May 12, 2005.
6. A prospective, randomized, multicenter FDA IDE study of the lumbar total disc replacement with the Charité™ artificial disc versus lumbar fusion: Part 1-Evaluation of clinical outcomes. Spine In press.
7. Shufflebatger HL. Surgeons, societies, and companies: Ethics and legalities. Spine 2001;26:1947-9.
8. Peilise F, Puig O, Rivas A, et al. Low fusion rate after L5-S1 laparoscopic anterior lumbar interbody fusion using twin stand-alone carbon fiber cages. Spine 2002;27:1665-9.
9. Brantigan JW. Re: Peilise F, Puig O, Rivas A, et al. Low fusion rate after L5-S1 laparoscopic antetior lumbar interbody fusion using twin stand-alone carbon fiber cages. Spine 2002;27:1665-1669. Spine 2003;28:520-1; author reply-1.
10. Santos EG, Polly DW, Jr., Mehbod AA, et al. Disc arthroplasty: lessons learned from total joint arthroplasty. Spine J 2004;4:182S-9S.
11. Button G, Gupta M, Barrett C, et al. Three- to six-year follow-up of stand-alone BAK cages implanted by a single surgeon. Spine J 2005;5:155-60.
12. Center of Devices and Radiological Health, Department of Health and Human Services, Food and Drug Administration. P040006b. Summary of Safety and Effectiveness. Available at: http://www.fda.gov/cdrh/PDF4 p040006b.pdf. Accessed May 12, 2005.
13. McAfee PC, Cunningham B, Holsapple G. et al. A prospective, randomized, multicenter, Food and Drug Administration. Investigational Device Exemption Study of lumbar total disc replacement with the Charité™ artificial disc versus lumbar fusion: Part II-Evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine. In press.
14. Depuy Spine, Inc. Charité™ Artificial Disc Training Coutse. Presented at: The Center for Spine Arthroplasty at the Endo-Surgery Institute; April 1-2, 2005; Cincinnati, OH.
15. Anderson PA, Sasso RC, Rouleau JP, et al. The Bryan Cervical Disc: Wear properties and early clinical results. Spine J 2004;4:303S-9S.
16. Santos EG, Polly DW Jr, Mehbod AA, et al. Disc arthroplasty: Lessons learned from total joint arthroplasty. Spine J 2004;4:182S-9S.
17. Depuy Spine, Inc., Charite artificial disk home page. Natural motion is back. Available at: http://www.charitedisc.com/charitedev/domestic/default.asp. Accessed May 12, 2005.
18. NPR. National Public Radio Morning Edition report on the Charité™ artificial disc and the Texas Back Institute. Available at: https://www.npr.org. Accessed May 12, 2005.