Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis

Abstract

BackgroundSince the introduction of rhBMP-2 (Infuse®) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP®) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures.MethodsThree hundred twenty-one (321) patients from three centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. The independent radiologist was blinded to the intervention, product, and surgeon information. Two hundred and twenty-six (226) patients received OsteoAMP with autologous local bone, while ninety-five (95) patients received Infuse with autologous local bone. Patients underwent radiographs (x-ray and/or CT) at standard postoperative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. Fusion was defined as radiographic evidence of bridging across endplates, or bridging from endplates to interspace disc plugs. Osteobiologic surgical supply costs were also analyzed to ascertain cost differences between OsteoAMP and rhBMP-2.ResultsOsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). The time required for OsteoAMP to achieve fusion was approximately 40% less than rhBMP-2 with approximately 70% fewer complications. Osteobiologic supply costs were 80.5% lower for OsteoAMP patients (73.7% lower per level) than for rhBMP-2.ConclusionsResults of this study indicate that OsteoAMP is a viable alternative to rhBMP-2 both clinically and economically when used in TLIF and LLIF spine procedures.

Clinical Validation of Allogeneic Morphogenetic Protein: Donor Intervariability, Terminal Irradiation and Age of Product is not Clinically Relevant

“…Data from the current study demonstrated over 98% fusion rates for both lumbar and cervical patients at 18 months. This confirms the results from previous studies using OsteoAMP where reported fusion results of 98.9% at 18 months in lumbar and 100% at 18 months in cervical cases when OsteoAMP was used as the biologic [22,23]. We found no biological adverse events, although one patient did develop a pseudarthrosis without a clear reason.…”

Bone regeneration strategies: Engineered scaffolds, bioactive molecules and stem cells current stage and future perspectives

“…It is being evaluated in transforaminal and lateral lumbar interbody fusion procedures as an alternative to rhBMP-2. In a clinical study, 226 patients received OsteoAMP with autologous local bone, while 95 patients received Infuse with autologous local bone [93]. The fusion rates were systematically higher and the time required to achieve fusion was approximately 40% less than rhBMP-2 with about 70% fewer complications.…”

The Few Who Made It: Commercially and Clinically Successful Innovative Bone Grafts

“…This is the case of OsteoAMP ® (Bioventus Surgical) and Augment ® bone graft (Wright Medical Group), the former made of an allogeneic-derived matrix, especially treated to preserve a cocktail of native growth factors and the latter composed of a collagen/tricalcium phosphate composite combined with platelet-derived growth factor (PDGF-BB). Both devices promoted bone ingrowth without the need of autograft harvesting in two clinical trials with patients undergoing transforaminal lumbar or lateral interbody fusion and ankle or hindfoot arthrodesis, respectively ( DiGiovanni et al, 2013 ; Roh et al, 2013 ; Krell and DiGiovanni, 2016 ).…”