Authors' objectives:

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).

Authors' recommendations: Evidence submitted to regulatory bodies in the United States and Canada indicates that the INFUSE(R) device appears safe. The largest number of spinal fusion cases using bone morphogenetic protein (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.

Authors' methods: Systematic review

Project Status: Completed

Year Published: 2004

URL for published report: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_bmp_030104.pdf

URL for additional information: http://www.hqontario.ca/evidence/publications-and-ohtac-recommendations/ohtas-reports-and-ohtac-recommendations/bone-morphogenetic-proteins-and-spinal-surgery-for-degenerative-disc-disease

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Medical Advisory Secretariat

Contact Address: Medical Advisory Secretariat, 20 Dundas Street West, 10th Floor, Toronto, ON M5G 2N6 CANADA. Tel: 416-314-1092l; Fax: 416-325-2364;

Contact Name: MASinfo.moh@ontario.ca

Contact Email: MASinfo.moh@ontario.ca

Copyright: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care