The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in orthopaedic applications.
Preclinical proof-of-concept, feasibility and efficacy studies in lower animals resulted in the accumulation of data that served as a backbone for clinical trials with the recombinant, osteogenic bone morphogenetic protein-2 (BMP-2). Among the important observations was the dependence of dose and carrier on the outcome for osseous union in relation to the animal model used. Clinical outcome data for spinal applications indicate better overall results compared with traditional controls that utilised autogenous iliac crest bone graft for fusion. Parameters include less blood loss, less operating room time and costs, better fusion outcomes and increased patient satisfaction. At this juncture, the long journey from the identification of BMP-2 in demineralised bone fraction to FDA approval for use in a singular orthopaedic application has been completed. It has been demonstrated to be safe, efficacious and cost-effective, leading to increased patient satisfaction and improved clinical outcome.
Khan
Safdar N
SN
Hospital for Special Surgery, Weill Medical College of Cornell University, New York, NY, USA.
Lane
Joseph M
JM
D001846:Bone Development / Q000187:drug effects*; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D050723:Fractures, Bone / Q000188:drug therapy / Q000628:therapy; D006801:Humans; D019637:Orthopedic Procedures; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use; D013123:Spinal Fusion; D016212:Transforming Growth Factor beta
C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2