Carragee et al respond

Spine Journal

Volumn 11, Issue 11, 2011, Pages 1083-1086

  Carragee, Eugene J ^a   Hurwitz, Eric L ^a   Weiner, Bradley K ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

AUTHOR; CANCER RISK; CLINICAL TRIAL (TOPIC); DRUG DELIVERY SYSTEM; FOOD AND DRUG ADMINISTRATION; FUNDING; HEALTH CARE COST; HUMAN; LEG PAIN; LETTER; MEDICAL DEVICE; MEDICAL LITERATURE; MORBIDITY; PATIENT CARE; POLICY; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; STUDY DESIGN; SYSTEMATIC ERROR;

EID: 84865860891     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2011.10.003     Document Type: Letter

References (20)

1. Carragee EJ, Hurwitz EL,Weiner BK.Acritical reviewof recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J 2011;11:471-91.
2. Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/ compression resistant matrix versus iliac crest bone graft. Spine 2006;31:2534-9. discussion 2540. (Pubitemid 44632234)
3. Glassman SD, Dimar JR, Burkus K, et al. The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers. Spine 2007;32:1693-8. (Pubitemid 47051857)
4. Medtronic Physician Registry. 2011. Available at: http://www.medtronic. com/about-medtronic/physician-collaboration/physican-registry/index. htm. Accessed January 17, 2011.
5. -2009 Annual Meeting Disclosure Index. Spine J 2009;9(10 Suppl 1): S214-38.
6. -2010 Annual Meeting Disclosure Index. Spine J 2010;10(9 Suppl 1): S157-80.
7. Howington P. Local spine surgeons in legal battle over royalties. Courier J 2011.Available at: http://www.ongo.com/v/249248/-1/8AC59839 B962BC77/local-spine-surgeons-in-legal-battle-over-royalties. Accessed September 29, 2011.
8. Carreyrou J. Senators look into Medtronic, doctors. Wall St J 2011. Available at: http://online.wsj.com/article/SB100014240527023040 70104576400032473761332.html. Accessed September 29, 2011.
9. Food and Drug Administration. Public Meeting Orthopedic and Rehabilitation Devices Advisory Panel. 2002. Proceedings transcript. Accessed September 29, 2011.
10. Biegelsen L, Huang L. Equity research: Medtronic, Inc. Spine Journal represents tip of icebergddowngrading shares. Downgrading to market perform. 2011.
11. Dimar JR, Glassman SD, Burkus JK, et al. Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am 2009;91:1377-86.
12. Moher D, Schulz KF, Altman D. TheCONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987-91. (Pubitemid 32366951)
13. Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8. (Pubitemid 39524916)
14. Food and Drug Administration. Food and Drug Administration Executive Summary for P050036Medtronic's AMPLIFYTM rhBMP-2 Matrix Orthopaedic and Rehabilitation Devices Advisory Panel. 2010. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisory Committee/OrthopaedicandRehabilitationDevicesPanel/ UCM220076. pdf. Accessed October 24, 2011.
15. Food and Drug Administration. Orthopaedic and Rehabilitation Devices Advisory Panel Meeting, July 27, 2010. Gaithersburg, MD. Proceeding transcript, page 123.
16. FDA Panel PackdP050036 pdf redacted version6-30-10-1.pdf. [June 2010].
17. Poynton AR, Lane JM. Safety profile for the clinical use of bone morphogenetic proteins in the spine. Spine 2002;27(16 Suppl 1):S40-8.
18. Boden SD, Kang J, Sandhu H, Heller JG. Use of recombinant human bone morphogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies. Spine 2002;27:2662-73. (Pubitemid 35425320)
19. Dawson E, Bae HW, Burkus JK, et al. Recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with an osteoconductive bulking agent in posterolateral arthrodesis with instrumentation. A prospective randomized trial. J Bone Joint Surg Am 2009;91:1604-13.
20. Carragee EJ, Bono CM, Scuderi GJ. Pseudomorbidity in iliac crest bone graft harvesting: the rise of rhBMP-2 in short-segment posterior lumbar fusion. Spine J 2009;9:873-9.