Abstract
BackgroundBoth the map3 Cellular Allogeneic Bone Graft® and recombinant human bone morphogenetic protein 2 (rhBMP-2, Infuse®) were developed to provide an alternative to iliac crest autograft, thus eliminating the morbidity associated with its harvest. The recent literature concerning adverse events associated with the use of rhBMP-2, however, highlights the need for a safe and effective alternative. The multipotent adult progenitor cells (MAPC) found in map3 allograft may provide this alternative. The purpose of this study is to report 1-year outcomes of patients treated via anterior lumbar interbody fusion (ALIF) using either map3 Cellular Allogeneic Bone Graft or rhBMP-2 for bony fusion.MethodsThis was a retrospective evaluation of 41 patients treated via ALIF with either map3 or rhBMP-2 in a polyetheretherketone cage with posterior stabilization at 1, 2, or 3 consecutive levels (L3-S1). Patients were equally divided between treatment groups. The Oswestry Disability Index (ODI) and visual analog scores (VAS) for pain were documented as part of the standard of care. An independent radiologist assessed bridging of bone, disc height, and lordosis. Primary outcome measures included radiographic analysis of fusion by plain film and CTs. Secondary clinical outcomes included visual analogue scale for neck and arm pain and low back disability index scores.ResultsThe overall fusion rate was 91%, with no significant difference between groups. Improvements in ODI and VAS were observed among all patients (p < 0.001), with no significant difference between groups for ODI (p = 0.966) or VAS (p = 0.251). There was no significant difference in terms of changes to disc height and lordosis between groups (p < 0.05). The rhBMP-2 group had increased post-operative complications when compared to the map3 group, but the low numbers precluded statistical analysis.ConclusionImprovements in radiographic and clinical findings were observed in both treatment groups one-year postoperatively. Map3 allograft demonstrated equivalent fusion rates to rhBMP-2. A review of surgical supply costs at the treatment facility favored map3 allograft for the treatment of patients with DDD undergoing an ALIF in 1–3 levels compared to rhBMP-2. Further studies to evaluate long-term outcomes and post-operative complications are required.
Highlights
Both the map3 Cellular Allogeneic Bone Graft® and recombinant human bone morphogenetic protein 2 were developed to provide an alternative to iliac crest autograft, eliminating the morbidity associated with its harvest
Avoiding the use of Iliac crest bone graft (ICBG) altogether has increased with the proliferation of reports indicating the effectiveness of additional graft options, such as bone marrow aspirate, local autogenous bone, allografts, synthetic materials, and recombinant human bone morphogenetic proteins
There was no significant difference between the two groups with respect to either Body mass index (BMI) (p = 0.847) or age (p = 0.633)
Summary
Both the map Cellular Allogeneic Bone Graft® and recombinant human bone morphogenetic protein 2 (rhBMP-2, Infuse®) were developed to provide an alternative to iliac crest autograft, eliminating the morbidity associated with its harvest. Avoiding the use of ICBG altogether has increased with the proliferation of reports indicating the effectiveness of additional graft options, such as bone marrow aspirate, local autogenous bone, allografts, synthetic materials, and recombinant human bone morphogenetic proteins (rhBMPs). Investigators demonstrated a trend towards a higher nonunion rate with rhBMP-2 compared to a historical control ALIF using FRAs with autologous iliac crest bone graft. These results appear to be caused by the aggressive resorptive phase of allograft incorporation, which occurs prior to the osteoinduction phase
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