Clinical evaluation of rhBMP-2/ACS in orthopedic trauma: a progress report.

Abstract

Recombinant human bone morphogenetic protein-2 (rhBMP-2) is an osteoinductive protein that plays a pivotal role in bone growth and regeneration. Studies conducted in many mammalian species and, most recently, human clinical studies, have provided definitive evidence of the ability of rhBMP-2 to induce bone. The findings of these studies provide a rationale for investigating whether rhBMP-2 therapy will be clinically useful in orthopedic practice. Consequently, we have initiated a clinical research program to evaluate the safety and efficacy of rhBMP-2 therapy in open tibial fractures. A prospective observational study (involving no rhBMP-2 treatment) was conducted to define an appropriate patient population for rhBMP-2 clinical trials and has provided critical information related to the design and execution of future studies. The rhBMP-2 clinical trials include a small pilot feasibility study and several larger studies. Data from the pilot feasibility study have demonstrated that implantation of rhBMP-2 (combined with an absorbable collagen sponge) is surgically feasible and safe. Larger, multicenter clinical studies are now ongoing in the United States and abroad.

• Authors: G E Riedel, A Valentin-Opran
• Journal: Orthopedics (Orthopedics) Vol. 22 Issue 7 Pg. 663-5 (Jul 1999) ISSN: 0147-7447 [Print] United States
• PMID: 10418860 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study)

Chemical References

• Bone Morphogenetic Proteins
• Recombinant Proteins

Topics

• Accidents, Traffic
• Adult
• Aged
• Bone Morphogenetic Proteins (administration & dosage)
• Combined Modality Therapy
• Evaluation Studies as Topic
• Feasibility Studies
• Female
• Follow-Up Studies
• Fracture Fixation, Internal (methods)
• Fracture Healing (drug effects, physiology)
• Fractures, Open (drug therapy, surgery)
• Humans
• Male
• Middle Aged
• Pilot Projects
• Recombinant Proteins
• Tibial Fractures (drug therapy, surgery)
• Treatment Outcome