THE EVIDENCE FOR BONE GRAFT SUBSTITUTES AND BONE MORPHOGENIC PROTEINS (BMPS) IN CLINICAL SPINAL SURGERY

Abstract

Background: Autologous bone graft remains the “gold standard”, but the associated morbidity and finite supply of tissue has resulted in surgeons seeking methods of enhancing healing with bone graft substitutes and bone morphogenic proteins (BMPs). There are 54 bone graft substitutes and 2 BMPs currently on sale in the UK. The aim of this study was to review the published clinical evidence in support of their use in spinal surgery.

Methods: The 19 manufacturers of bone graft substitutes and BMPs were contacted asking for details of their products on the market. A systematic literature review was conducted using the ISI Web of Knowledge, EMBASE (1980–2008) and OVID databases. Publications providing clinical data were classified according to the hierarchy of clinical evidence published in the Journal of Bone and Joint Surgery Am in 2003. Level I evidence is a prospective randomised control trial with definitive results to support the use of an intervention in a clinical setting. Level V evidence is isolated case reports. A Grade of recommendation A-i was accredited to each product to assist the clinical spinal surgeon in making decisions on which product to use based on the evidence in the literature.

Results: 102 clinical studies found, most of which were level IV or V evidence. Both BMPs, InductOS® and OP-1® have Level I papers and have Grade A recommendation. There is very poor evidence for the use of bone graft substitutes in spinal surgery with no products receiving Grade A recommendation and only 6 out of 54 products having Grade B recommendation.

Conclusions: There is a lack of evidenced based clinical data for the use of bone graft substitutes in spinal surgery. Regarding BMPs there is good evidence for the use of these products in spinal surgery but surgeons must be aware of the reported complications.