Abstract
PurposeThis paper documents the existing evidence on bone morphogenetic proteins (BMPs) use for the treatment of bone fractures, non-union, and osteonecrosis, through a review of the clinical literature, underlying potential and limitations in terms of cost effectiveness and risk of complications.MethodsA systematic review was performed on the PubMed database using the following string: (bone morphogenetic proteins OR BMPs) and (bone repair OR bone regeneration) including papers from 2000 to 2016. The search focused on clinical trials dealing with BMPs application to favor bone regeneration in bone fractures, non-union, and osteonecrosis, in English language, with level of evidence I, II, III, and IV. Relevant data (type of study, number of patients, BMPs delivery material, dose, site, follow-up, outcome, and adverse events) were extracted and analyzed.ResultsForty-four articles met the inclusion criteria: 10 randomized controlled trials (RCTs), 7 comparative studies, 18 case series, and 9 case reports. rhBMP-2 was documented mainly for the treatment of fractures, and rhBMP-7 mainly for non-unions and osteonecrosis. Mixed results were found among RCTs and comparative papers: 11 reported positive results for BMPs augmentation, 3 obtained no significant effects, and 2 showed negative results. The only study comparing the two BMPs showed a better outcome with rhBMP-2 for non-union treatment.ConclusionClinical evidence on BMPs use for the treatment of fractures, non-union, and osteonecrosis is still controversial, with the few available reports being mainly of low quality. While positive findings have been described in many studies, mixed results are still present in the literature in terms of efficacy and adverse events. The difficulties in drawing clear conclusions are also due to the studies heterogeneity, mainly in terms of different BMPs applied, with different concomitant treatments for each bone pathology. Therefore, further research with well-designed studies is needed in order to understand the real potential of this biological approach to favour bone healing.
Highlights
Bone healing is a complex process that requires the synergistic action of cells, cytokines, and growth factors (GFs) [1, 2]
While positive findings have been described in many studies, mixed results are still present in the literature in terms of efficacy and adverse events
Among several GFs involved in skeletal remodeling and repair, the discovery by Urist of bone morphogenetic proteins (BMPs) at the end of the nineteenth century [4] was of great importance in understanding the complex biological cascade of osteogenesis
Summary
Bone healing is a complex process that requires the synergistic action of cells, cytokines, and growth factors (GFs) [1, 2]. There are two commercially available BMPs, recombinant human rh BMP-2 and rhBMP-7 They have been tested in several preclinical studies showing the ability to induce bone regeneration [9,10,11], and evaluated in clinical trials to treat various bone disorders such as non-unions, open fractures, and osteonecrosis [12,13,14,15,16,17]. RhBMP-7 received official approval by EMA in 2004 as Osteogenic Protein-1 (OP-1® or Osigraft®) implant for the treatment of recalcitrant long bone non-unions [19]. While BMPs seemed promising for bone regeneration, potential and limitations remains debated
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