Reply to "a critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: Emerging safety concerns and lessons learned"

Spine Journal

Volumn 11, Issue 11, 2011, Pages 1082-1083

  Dimar, John R ^a   Glassman, Steven D ^a   Burkus, J Kenneth ^a   Pryor, Philip W ^a   Hardacker, James W ^a   Carreon, Leah Y ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM PHOSPHATE; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; BONE MORPHOGENETIC PROTEIN 2; TRANSFORMING GROWTH FACTOR BETA;

ARTHRALGIA; BACKACHE; BASAL CELL CARCINOMA; BONE GRAFT; BURSITIS; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HIP PAIN; HUMAN; ILIAC CREST; LARYNX CANCER; LEG CRAMP; LEG PAIN; LETTER; LUNG CANCER; LYMPHOMA; OVARY CANCER; PANCREAS CANCER; PATIENT SAFETY; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROSTATE CANCER; RADICULOPATHY; SPINE SURGERY; SQUAMOUS CELL CARCINOMA; CLINICAL TRIAL (TOPIC); CONFLICT OF INTEREST; METHODOLOGY; NOTE; SPINE FUSION; STANDARD;

BONE MORPHOGENETIC PROTEIN 2; CLINICAL TRIALS AS TOPIC; CONFLICT OF INTEREST; HUMANS; RESEARCH DESIGN; SPINAL FUSION; TRANSFORMING GROWTH FACTOR BETA;

EID: 84858754404     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2011.09.029     Document Type: Letter

References (4)

1. Carragee EJ, Hurwitz EL,Weiner BK. A critical review of 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 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.
3. 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)
4. Food and Drug Adminstration. Food and Drug Administration Executive Summary for P050036Medtronic's AMPLIFY- RhBMP-2 Matrix Orthopaedic and Rehabilitation Devices Advisory Panel. 2010.Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/Committees MeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/ OrthopaedicandRehabilitationDevicesPanel/ UCM220079.pdf. Accessed July 9, 2011.