Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up

Spine Journal

Volumn 9, Issue 5, 2009, Pages 374-386

  Guyer, Richard D ^a   McAfee, Paul C ^b   Banco, Robert J ^c   Bitan, Fabian D ^d   Cappuccino, Andrew ^e   Geisler, Fred H ^f   Hochschuler, Stephen H ^a   Holt, Richard T ^g   Jenis, Louis G ^c   Majd, Mohamed E ^g   Regan, John J ^h   Tromanhauser, Scott G ^c   Wong, Douglas C ⁱ   Blumenthal, Scott L ^a  

^a TEXAS BACK INSTITUTE   (United States)

^b Scoliosis and Spine Center   (United States)

^c Boston Spine Group   (United States)

^d Lennox Hill Hospital   (United States)

^e Buffalo Spine Surgery   (United States)

^f Illinois Neuro Spine Center   (United States)

^g Spine Surgery   (United States)

^h Goldstein and Penenberg Orthopedic Associates   (United States)

ⁱ Panorama Orthopedics   (United States)

Author keywords

5 year follow up; Arthrodesis; Arthroplasty; Randomized controled trial

Indexed keywords

ADULT; ARTHRODESIS; ARTHROPLASTY; ARTICLE; ARTIFICIAL DISC; AUTOGRAFT; BONE GRAFT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVICE; DISABILITY; EMPLOYMENT; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; ILIAC CREST; INTERVERTEBRAL DISK; INTERVERTEBRAL DISK DEGENERATION; INTERVERTEBRAL DISK DISEASE; LENGTH OF STAY; LUMBAR SPINE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OSSIFICATION; OSWESTRY DISABILITY INDEX; PAIN ASSESSMENT; PATIENT SAFETY; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RANGE OF MOTION; SCORING SYSTEM; SHORT FORM 36; SPINE RADIOGRAPHY; SPINE SURGERY; STATISTICAL ANALYSIS; SURGICAL EQUIPMENT; TOTAL DISC REPLACEMENT; TREATMENT FAILURE; TREATMENT OUTCOME; VISUAL ANALOG SCALE;

ADULT; ARTHROPLASTY, REPLACEMENT; EQUIPMENT FAILURE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTERVERTEBRAL DISK; INTERVERTEBRAL DISK DISPLACEMENT; JOINT PROSTHESIS; LUMBAR VERTEBRAE; MALE; MIDDLE AGED; PAIN MEASUREMENT; RANGE OF MOTION, ARTICULAR; RECOVERY OF FUNCTION; SPINAL FUSION; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 64849092869     PISSN: 15299430     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.spinee.2008.08.007     Document Type: Article

References (35)

1. Link H.D. Letter to the Editor concerning "Charite total disc replacement: clinical and radiographical results after an average follow-up of 17 years" (M. Putzier et al.). [comment]. Eur Spine J 15 (2006) 514-517
2. Buttner-Janz K. Letter to the Editor concerning "Charite total disc replacement: clinical and radiographical results after an average follow-up of 17 years" (M. Putzier et al.). Eur Spine J 15 (2006) 510-513
3. Cunningham B.W., Gordon J.D., Dmitriev A.E., Hu N., and McAfee P.C. Biomechanical evaluation of total disc replacement arthroplasty: an in vitro human cadaveric model. Spine 28 (2003) S110-S117
4. Cunningham B.W., Dmitriev A.E., Hu N., and McAfee P.C. General principles of total disc replacement arthroplasty: seventeen cases in a nonhuman primate model. Spine 28 (2003) S118-S124
5. Griffith S.L., Shelokov A.P., Buttner-Janz K., Lemaire J.P., and Zeegers W.S. A multicenter retrospective study of the clinical results of the LINK SB Charite intervertebral prosthesis. The initial European experience. Spine 19 (1994) 1842-1849
6. Cinotti G., David T., and Postacchini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine 21 (1996) 995-1000
7. Lemaire J.P., Carrier H., SariAli e, Skalli W., and Lavaste F. Clinical and radiological outcomes with the Charite artificial disc: a 10-year minimum follow-up. [erratum appears in J Spinal Disord Tech. 2006 Feb;19(1):76 Note: Sari Ali, El-Hadi (corrected to Sariali, El-hadi)]. J Spinal Disord Tech 18 (2005) 353-359
8. Putzier M., Funk J.F., Schneider S.V., et al. Charite total disc replacement-clinical and radiographical results after an average follow-up of 17 years. [see comment]. Eur Spine J 15 (2006) 183-195
9. David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITE artificial disc in 106 patients. Spine 32 (2007) 661-666
10. Blumenthal S., McAfee P.C., Guyer R.D., et al. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. [erratum appears in Spine. 2005 Oct 15;30(20):2356]. Spine 30 (2005) 1565-1575
11. McAfee P.C., 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 CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine 30 (2005) 1576-1583
12. Brazier J.E., Harper R., Jones N.M., et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 305 (1992) 160-164
13. Geisler F.H. Surgical technique of lumbar artificial disc replacement with the Charite artificial disc. Neurosurgery 56 Suppl. 57 (2005)
14. Kuslich S.D., Ulstrom C.L., Griffith S.L., Ahern J.W., and Dowdle J.D. The Bagby and Kuslich method of lumbar interbody fusion. History, techniques, and 2-year follow-up results of a United States prospective, multicenter trial. Spine 23 (1998) 1267-1278
15. Zhao K., Yang C., Zhao C., and An K.N. Assessment of non-invasive intervertebral motion measurements in the lumbar spine. J Biomech 38 (2005) 1943-1946
16. Nathan H. Osteophytes of the vertebral column: an anatomical study of their development according to age, race, and sex with considerations as to their etiology and significance. J Bone Joint Surg Am 44 (1962) 243-268
17. McAfee P.C., Fedder I.L., Saiedy S., Shucosky E.M., and Cunningham B.W. SB Charite disc replacement: report of 60 prospective randomized cases in a US center. J Spinal Disord Tech 16 (2003) 424-433
18. Food and Drug Administration. Guidance document for the preparation of IDEs for spinal systems. 2000.
19. ®-L total disc replacement-P050010: summary of safety and effectiveness data; 2006.
20. Hagg O., Fritzell P., and Nordwall A. Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. [see comment]. Eur Spine J 12 (2003) 12-20
21. Polly Jr. D.W., Glassman S.D., Schwender J.D., et al. SF-36 PCS benefit-cost ratio of lumbar fusion comparison to other surgical interventions: a thought experiment. Spine 32 Suppl 6 (2007)
22. White A.W., and Panjabi M.M. Clinical biomechanics of the spine. 2nd ed. (1990), Lippincott Williams & Wilkins, Philadelphia, PA
23. Blackwelder W.C., and Chang M.A. Sample size graphs for "proving the null hypothesis. Control Clin Trials 5 (1984) 97-105
24. Glaser J., Stanley M., Sayre H., Woody J., Found E., and Spratt K. A 10-year follow-up evaluation of lumbar spine fusion with pedicle screw fixation. Spine 28 (2003) 1390-1395
25. Kuslich S.D., Danielson G., Dowdle J.D., et al. Four-year follow-up results of lumbar spine arthrodesis using the Bagby and Kuslich lumbar fusion cage. Spine 25 (2000) 2656-2662
26. Burkus J.K., Gornet M.F., Dickman C.A., and Zdeblick T.A. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech 15 (2002) 337-349
27. Food and Drug Administration. INFUSE™ bone graft / LT-CAGE™ lumbar tapered fusion device. Summary of effectiveness and data P000058; 2002.
28. Badawy W.S., El Masry M.A., Radwan Y.A., and El Haddidi T.T. Results of instrumented posterolateral fusion in failed back surgery. Int Orthop 30 (2006) 305-308
29. Wood K., Buttermann G., Mehbod A., et al. Operative compared with nonoperative treatment of a thoracolumbar burst fracture without neurological deficit. A prospective, randomized study. [see comment; erratum appears in J Bone Joint Surg Am. 2004 Jun;86-A(6):1283]. J Bone Joint Surg Am 85-A (2003) 773-781
30. Fairbank J.C., and Pynsent P.B. The Oswestry disability index. Spine 25 (2000) 2940-2952
31. Button G., Gupta M., Barrett C., Cammack P., and Benson D. Three- to six-year follow-up of stand-alone BAK cages implanted by a single surgeon. Spine J 5 (2005) 155-160
32. Pavlov P.W., Spruit M., Havinga M., Anderson P.G., van L.J., and Jacobs W.C. Anterior lumbar interbody fusion with threaded fusion cages and autologous bone grafts. Eur Spine J 9 (2000) 224-229
33. Pearcy M.J. Stereo radiography of lumbar spine motion. Acta Orthop Scand 212 Suppl (1985) 1-45
34. Posner I., White III A.A., Edwards W.T., and Hayes W.C. A biomechanical analysis of the clinical stability of the lumbar and lumbosacral spine. Spine 7 (1982) 374-389
35. Panjabi M., Malcolmson G., Teng E., Tominaga Y., Henderson G., and Serhan H. Hybrid testing of lumbar CHARITE discs versus fusions. Spine 32 (2007) 959-966