SPINAL FUSION

Systematic review and meta-analysis of the safety and efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion

Background

Human bone morphogenic protein-2 (rhBMP-2) is used in orthopaedic and spinal surgery to promote fusion. Following 2002 FDA approval for use in anterior lumbar fusion (ALIF) surgery, numbers of spinal procedures using rhBMP-2 grew rapidly, including many in off-label indications. Recently, a number of studies have raised concern over high rates of adverse events (AE) some of which are potentially life-threatening but were not apparent from publications of the licensing studies. The efficacy and safety of rhBMP-2 is therefore under considerable scrutiny and a robust re-evaluation of the research evidence is vital.

The manufacturers of rhBMP-2 (Medtronic Inc) have released all of its clinical research data that are relevant to the use of rhBMP-2 to Yale University for independent scrutiny and review. Yale has commissioned two academic groups to carry out independent and unrestricted systematic reviews of the safety and efficacy of rhBMP-2 in spinal fusion, including re-analysis of the individual participant data from Medtronic studies. CRD is one of these groups.

Our approach will embed an individual participant data meta-analysis and systematic review of the safety and efficacy of rhBMP-2 within a wider exploration of data analysis, reporting and publishing practice.

Conducted by: Jennifer Brown¹, Morag Heirs¹, Julian Higgins¹, Mark Rodgers¹

, Mark Simmonds¹, Lesley Stewart¹, Kath Wright¹ with Richard Mannion²,

1. Centre for Reviews and Dissemination; 2. Academic Neurosurgery Unit, Addenbrookes Hospital, Cambridge, UK

Further details

Project page on Yale School of Medicine website

Funding

Yale University competitive bid

Page last updated: 18 July 2012