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Bone morphogenic proteins for use in spinal fusion
Bone morphogenic proteins are naturally produced cell regulating proteins (TGF-B family) necessary for bone healing and regeneration, but also involved in other tissue configuration processes. Recombinant DNA methods have been used to produce higher quantities of bone morphogenic proteins than could be harvested from cadaver sources (due to minute naturally available amounts) for commercial application. Recombinant BMP products have been used since 2001 in procedures where bone healing or fusion is required; they are used in conjunction with collagen scaffolding materials and/or metallic cages.
BMP products provide the potential to avoid bone harvesting procedures necessary for use of autograft (self donated bone material), or to avoid allograft (use of bone from cadavers). Autograft requires bone harvesting, a separate surgical procedure that itself may result in pain and carries some risk related to the procedure and removal of bone, frequently from the iliac crest (hip). If BMP is a safe and effective alternative to autograft, patients may avoid a procedure and associated risk.
Primary criteria ranking
- Safety = Medium
- Efficacy = Medium
- Cost = High
- Draft report published: January 12, 2012
- Public comment period: January 12 - 30, 2012
- Final report published: February 14, 2012
- HTCC public meeting: March 16, 2012