Bone morphogenetic proteins & spinal surgery for degenarative disc disease: an evidence-based analysis.
OBJECTIVE
This review is intended to summarize the evidence of safety and effectiveness of a recently licensed spinal fusion surgery device that includes a recombinant human bone morphogenetic protein (BMP).
BMP are proteins that occur naturally in the matrix of human bone and stimulate bone growth. For spinal surgery, BMP must be delivered to the vertebral level where bone growth is desired. The BMP device currently available in Canada comprises a specific cage device and a bovine collagen sponge that delivers BMP. This sponge must be implanted in combination with this specific cage device from the same manufacturer. The device is marketed under the trade name INFUSE™ and provides an alternative to autologous bone graft in spinal fusion.


METHODS
Published literature identified through searches of MEDLINE and EMBASE was supplemented with material submitted by the device manufacturer as part of regulatory approval in the United States and available through the public access area of the website of the Food and Drug Administration.


RESULTS
Evidence submitted to regulatory bodies in the USA and Canada indicates that the INFUSE™ device appears safe. The largest number of spinal fusion cases using BMP devices has been for anterior lumbar interbody fusion. Although radiologic fusion occurs at a consistently faster rate among recipients of the BMP device than among recipients of autologous bone grafts, clinical outcomes (pain and disability) appear no different. Regardless of technique, improvements in pain and disability are reported by similar proportions of participants in all the arms of all the trials. BMP devices for cervical fusion have yet to be approved in Canada but one small scale trial has reported radiologic fusion in all participants in both BMP and autologous bone graft arms and improvement in neck pain scores for all participants. BMP devices for lumbar fusion are licensed, safe and appear equivalent to autologous bone graft procedures for spinal fusion in terms of patient outcomes with the notable exception that patients undergoing autologous bone graft report pain at the donor site. Laparoscopic approaches yield reductions in postoperative length of stay compared to conventional open approaches.