Use of recombinant human bone morphogenetic protein-2 as an adjunct in posterolateral lumbar spine fusion: a prospective CT-scan analysis at one and two years.
ABSTRACT This study determines whether recombinant human bone morphogenetic protein-2 (rhBMP-2) (12 mg at the rate of 1.5 mg/mL) delivered on an absorbable collagen sponge with an added bulking agent can increase posterolateral lumbar spine fusion success rates and decrease time for fusion with autogenous bone grafts.
A prospective, single institution, clinical case-matched, radiographic, cohort study was undertaken. A total of 52 patients underwent posterolateral lumbar arthrodesis with pedicle screw instrumentation. The experimental group (n=41) underwent placement of Iliac crest bone graft (ICBG) with InFUSE (12 mg/level at the rate of 1.5 mg/mL). The control group (n=11) consisted of sex-matched patients, consecutively collected over the same time period with an instrumented posterolateral arthrodesis and ICBG placed in the intertransverse space.
Thin-cut (2 mm) axial, coronal, and sagittal reconstructions were blindly evaluated for evidence of bridging bone and cortication of the fusion mass by 3 separate reviewers. Fusions were graded and an overall score was given to the quality of the fusion mass.
Fifty patients (ICBG alone n=11; ICBG/rhBMP-2 n=39) were available for CT evaluation at 2-year follow-up. An overall 97% (68/70 levels; Definite+Probably Fused) fusion rate in the rhBMP-2 group was achieved as compared to the 77% fusion rate (17/22 levels) in the ICBG alone group (P<0.05). In the rhBMP-2 group, 92% of the patients (36/39 patients) received an overall excellent subjective fusion rating as compared to 27% (3/11) in the control group (P<0.05). There was no computed tomographic evidence of soft-tissue ossification, dural ossification, or laminar bone regrowth in any patient.
The adjunctive use of rhBMP-2 and ICBG seems to be safe and results in significantly larger and more consistent posterolateral fusion masses.
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ABSTRACT: Study Design. A retrospective cohort study with chart reviewObjective. To determine if there is difference in the operative nonunion rates with and without the use of Bone Morphogenic Protein (BMP) after spinal fusions by analyzing data from an integrated healthcare system's spine registry.Summary of Background Data. BMP was first approved in 2002 for use in single-level anterior lumbar fusions. Follow-up studies have advocated its use in reducing the need for reoperations for nonunions. Recent studies, however, have questioned these conclusions and the usefulness of BMP in spinal fusions has been highly debated.Methods. We identified 9425 spinal fusion cases between 2009 and 2011 from a spine registry in a large integrated healthcare organization. Patient characteristics, diagnosis, operative times, length of stay, and re-operations were extracted from the registry. Re-operations for nonunions were adjudicated via chart review. Cox regression models were used to evaluate the risk of re-operation while adjusting for confounders.Results. In our cohort, there were 5,456 BMP cases and 3,969 Non-BMP cases. The mean age was 60.4 years (SD = 12.9), with the majority being females (53%). The median follow-up time was 1.2 years (IQR: 0.6-2.0). Re-operation rates for BMP vs Non-BMP nonunions for all fusions cases with ≥ 1-year (1.9% vs 2.2%) and ≥ 2-years follow-up (2.3% vs 2.6%) were not statistically significantly different. Operative nonunion rates did not reach statistical significance for different spine regions and for different fused columns (anterior only, posterior only or combined).After controlling for differences in patient characteristics, operative times, levels fused, and spinal regions, the risk of re-operation in the BMP versus the Non-BMP group was 0.67 (95% CI: 0.42-1.06).Conclusion. In this large cohort of spinal fusions at all spine regions involving all fused columns with and without BMP we found no statistically significant difference in operative nonunion rates.Spine 07/2014; 39(22). DOI:10.1097/BRS.0000000000000534 · 2.45 Impact Factor
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ABSTRACT: During recent decades the utilisation of growth factors, especially BMPs, has received an increasing interest in orthopaedic surgery. For clinical implantation the two main options are demineralised bone matrix (DBM) and recombinant bone morphogenetic proteins (rhBMP). Many clinical studies agree on an equivalent osteoinductive effect between DBM, BMPs and autologous bone graft; however, the different origins and processing of DBM and rhBMP may introduce some fluctuations. Their respective characteristics are reviewed and possible interactions with their effectiveness are analysed. The main difference concerns the concentration of BMPs, which varies to an order of magnitude of 106 between DBM and rhBMPs. This may explain the variability in efficiency of some products and the adverse effects. Currently, considering osteoinductive properties, safety and availability, the DBM seems to offer several advantages. However, if DBM and rhBMPs are useful in some indications, their effectiveness and safety can be improved and more evidence-based studies are needed to better define the indications.International Orthopaedics 10/2014; DOI:10.1007/s00264-014-2562-0 · 2.02 Impact Factor
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ABSTRACT: There is a growing socio-economic need for effective strategies to repair damaged bone resulting from disease, trauma and surgical intervention. Bone tissue engineering has received substantial investment over the last few decades as a result. A multitude of studies have sought to examine the efficacy of multiple growth factors, delivery systems and biomaterials within in vivo animal models for the repair of critical-sized bone defects. Defect repair requires recapitulation of in vivo signalling cascades, including osteogenesis, chondrogenesis and angiogenesis, in an orchestrated spatiotemporal manner. Strategies to drive parallel, synergistic and consecutive signalling of factors including BMP-2, BMP-7/OP-1, FGF, PDGF, PTH, PTHrP, TGF-β3, VEGF and Wnts have demonstrated improved bone healing within animal models. Enhanced bone repair has also been demonstrated in the clinic following European Medicines Agency and Food and Drug Administration approval of BMP-2, BMP-7/OP-1, PDGF, PTH and PTHrP. The current review assesses the in vivo and clinical data surrounding the application of growth factors for bone regeneration. This review has examined data published between 1965 and 2013. All bone tissue engineering studies investigating in vivo response of the growth factors listed above, or combinations thereof, utilising animal models or human trials were included. All studies were compiled from PubMed-NCBI using search terms including ‘growth factor name’, ‘in vivo’, ‘model/animal’, ‘human’, and ‘bone tissue engineering’. Focus is drawn to the in vivo success of osteoinductive growth factors incorporated within material implants both in animals and humans, and identifies the unmet challenges within the skeletal regenerative area.European cells & materials 10/2014; 28:166-208. · 4.89 Impact Factor