Summary. In this study, OsteoAMP® bone graft showed superior fusion rates as compared to rhBMP-2 at all timepoints (p<0.004). Additionally, OsteoAMP® bone graft had >80% few adverse events as compared to rhBMP-2. Introduction. Adverse events and complications related to use of rhBMP-2 have raised many ethical, legal, and reimbursement concerns for surgeons. OsteoAMP® bone graft is an allograft derived growth factor, rich in osteoinductive, angiogenic, and mitogenic proteins. The following data displays a blinded, multi -center study evaluating and comparing fusion outcomes between rhBMP-2 and OsteoAMP® bone graft. Patients & Methods. A total of 254 consecutive patients (383 total levels) were treated with TLIF or LLIF spine fusion procedures. A group of 70 patients (53.3 ± 11.1 y/o) were treated with rhBMP-2 (Infuse®/Inductos®, Medtronic) and local bone inside of a PEEK interbody cage with an average of 1.44 levels per surgery. A group of 184 patients (60.5 ± 13.1 y/o) were treated with OsteoAMP® (Advanced Biologics) and local bone inside of a PEEK interbody cage with an average of 1.53 levels per surgery. Fusion assessments were made by a blinded independent radiologist based on radiograph and CT images at 6w, 3m, 6m, 12m, and 18m follow up. Radiographically evident adverse events were also assessed in a blinded manner by an independent radiologist. Results. Overall fusion analysis showed superiority in efficacy of OsteoAMP® over rhBMP-2 at all time points (p<0.004). Use of rhBMP-2 produced limited early fusions at 6 months (22.7%) yet improved at 1 year (71.4%). OsteoAMP® facilitated fusion for the majority of patients by 6 months (54.1%) and nearly all patients within 1 year (93.9%). At 18 months, 99.3% of OsteoAMP® patients had fused while the rhBMP-2 arm had an 86.7% fusion rate. Total time for fusion for OsteoAMP® was approximately half that of rhBMP-2 at 211.4 days and 407.1 days respectively. A subset cohort of 47 patients in the rhBMP-2 arm had OsteoAMP® packed anterior to the PEEK cage. When OsteoAMP® was used as an extender to rhBMP-2 in this manner, fusion rates increased at all timepoints (p=0.05 at 18 months) over patients that only had rhBMP-2 and local bone within the disc space. Though, the fusion rates of OsteoAMP® without rhBMP-2 remained higher than the rhBMP-2/local bone/OsteoAMP® extender cohort at all timepoints (p<0.05). To further isolate the effect of OsteoAMP, a subset cohort of 52 patients within the OsteoAMP® treatment arm in the absence of rhBMP-2 did not utilise bone marrow aspirate. The fusion rates of patients within this cohort was statistically higher at 6 months but did not show statistically higher fusion rates at 3 months, 12 months, or 18 months (p>0.12). When compared to the rhBMP-2 study arm, patients within the OsteoAMP® arm that did not receive bone marrow aspirate demonstrated higher fusion rates at all time points (p<0.04 at 12 and 18 months). The rhBMP-2 arm had more than 5 times the incidence of radiologically evident adverse events (osteolysis and ectopic bone formation) compared to the OsteoAMP® arm (43.3% vs. 8.2%, respectively). Discussion. Despite its use with an older patient population and a higher number of levels per surgery, OsteoAMP® has shown great promise as a faster and safer alternative to rhBMP-2 in lumbar spine surgery

Introduction and Objective. Posterior and transforaminal lumbar interbody fusion (PLIF, TLIF) represent the most popular techniques in performing an interbody fusion amongst spine surgeons. Pseudarthrosis, cage migration, subsidence or infection can occur, with subsequent failed surgery, persistent pain and patient’ bad quality of life. The goal of revision fusion surgery is to correct any previous technical errors avoiding surgical complications. The most safe and effective way is to choose a naive approach to the disc. Therefore, the anterior approach represents a suitable technique as a salvage operation. The aim of this study is to underline the technical advantages of the anterior retroperitoneal approach as a salvage procedure in failed PLIF/TLIF analyzing a series of 32 consecutive patients. Materials and Methods. We performed a retrospective analysis of patients’ data in patients who underwent ALIF as a salvage procedure after failed PLIF/TLIF between April 2014 to December 2019. We recorded all peri-operative data. In all patients the index level was exposed with a minimally invasive anterior retroperitoneal approach. Results. Thirty-two patients (average age: 46.4 years, median age 46.5, ranging from 21 to 74 years hold- 16 male and 16 female) underwent salvage ALIF procedure after failed PLIF/TLIF were included in the study. A minimally invasive anterior retroperitoneal approach to the lumbar spine was performed in all patients. In 6 cases (18.7%) (2 infection and 4 pseudarthrosis after stand-alone IF) only anterior revision surgery was performed. A posterior approach was necessary in 26 cases (81.3%). In most of cases (26/32, 81%) the posterior instrumentation was overpowered by the anterior cage without a previous revision. Three (9%) intraoperative minor complications after anterior approach were recorded: 1 dural tear, 1 ALIF cage subsidence and 1 small peritoneal tear. None vascular injuries occurred. Most of patients (90.6%) experienced an improvement of their clinical condition and at the last follow-up no mechanical complication occurred. Conclusions. According to our results, we can suggest that a favourable clinical outcome can firstly depend from technical reasons an then from radiological results. The removal of the mobilized cage, the accurate endplate and disc space preparation and the cage implant eliminate the primary source of pain reducing significantly the axial pain, helping to realise an optimal bony surface for fusion and enhancing primary stability. The powerful disc distraction given by the anterior approach allows inserting large and lordotic cages improving the optimal segmental lordosis restoration