Bone morphogenetic protein (BMP) for fracture healing in adults.

BACKGROUND: Delay in fracture healing is a complex clinical and economic issue for patients and health services. OBJECTIVES: To assess the incremental effectiveness and costs of bone morphogenetic protein (BMP) on fracture healing in acute fractures and nonunions compared with standards of care. SEARCH STRATEGY: We searched The Cochrane Library (2008, Issue 4), MEDLINE, and other major health and health economics databases (to October 2008). SELECTION CRITERIA: Randomised controlled trials (RCTs) and full or partial economic evaluations of BMP for fracture healing in skeletally mature adults. DATA COLLECTION AND ANALYSIS: All clinical and economic data were extracted by one author and checked by another. MAIN RESULTS: Eleven RCTs, all at high risk of bias, and four economic evaluations were included. Apart from one study, the times to fracture healing were comparable between the BMP and control groups. There was some evidence for increased healing rates, without requiring a secondary procedure, of BMP compared with usual care control in acute, mainly open, tibial fractures (risk ratio (RR) 1.19, 95% CI 0.99 to 1.43). The pooled RR for achieving union for nonunited fractures was 1.02 (95% CI 0.90 to 1.15). One study found no difference in union for patients who had corrective osteotomy for radial malunions. Data from three RCTs indicated that fewer secondary procedures were required for acute fracture patients treated with BMP versus controls (RR 0.65, 95% CI 0.50 to 0.83). Adverse events experienced were infection, hardware failure, pain, donor site morbidity, heterotopic bone formation and immunogenic reactions. The evidence on costs for BMP-2 for acute open tibia fractures is from one large RCT. This indicates that the direct medical costs associated with BMP would generally be higher than treatment with standard care, but this cost difference may decrease as fracture severity increases. Limited evidence suggests that the direct medical costs associated with BMP could be offset by faster healing and reduced time off work for patients with the most severe open tibia fractures. AUTHORS' CONCLUSIONS: This review highlights a paucity of data on the use of BMP in fracture healing as well as considerable industry involvement in currently available evidence. There is limited evidence to suggest that BMP may be more effective than controls for acute tibial fracture healing, however, the use of BMP for treating nonunion remains unclear. The limited available economic evidence indicates that BMP treatment for acute open tibial fractures may be more favourable economically when used in patients with the most severe fractures.

A cost analysis of treatment of tibial fracture nonunion by bone grafting or bone morphogenetic protein-7.

The parameter of health economics in the use of any contemporary medical module plays a dominant role in decision making. A prospective nonrandomised comparative study of the direct medical costs on the first attempt of treating aseptic nonunions of tibial fractures, with either autologous-iliac-crest-bone-graft (ICBG) or bone morphogenetic protein-7 (BMP-7), is presented. Twenty-seven consecutive patients, who were successfully treated for fracture nonunions, were divided into two groups. Group 1 (n = 12) received ICBG and group 2 (n = 15) received BMP-7. All patients healed their nonunions, and the financial analysis presented represents a best-case scenario. Three out of 12 of the ICBG group required revision surgery while just one out of 15 required it in the BMP-7 group. Average hospital stay was 10.66 vs. 8.66 days, time-to-union 6.9 vs. 5.5 months, hospitals costs pound2,133.6 vs. pound1,733.33, and theatre costs were pound2,413.3 vs. pound906.67 for the ICBG and BMP-7 groups, respectively. The BMP-7 cost was pound3002.2. Fixation-implant was pound696.4 vs. pound592.3, radiology pound570 vs. pound270, outpatient pound495.8 vs. pound223.33, and other costs were pound451.6 vs. pound566.27 for the ICBG and BMP-7 groups, respectively. The average cost of treatment with BMP-7 was 6.78% higher (P = 0.1) than with ICBG, and most of this (41.1%) was related to the actual price of the BMP-7. In addition to the satisfactory efficacy and safety of BMP-7 in comparison to the gold standard of ICBG, as documented in multiple studies, its cost effectiveness is advocated favourably in this analysis.