We have an ongoing prospective PLF study currently evaluating the safety and effectiveness of OSTEOAMP.
The potential limitations of the retrospective spine fusion studies include the following. Retrospective analysis limited by availability of radiographs and medical record data. Endpoint of interest limited to radiographic assessment of fusion and radiographic evidence of complications, with no corresponding clinical outcomes or general adverse events. Data from a subset of the patients may have been included in other retrospective analyses. Use of adequate sample sizes to detect differences in variables explored, including comparisons between OSTEOAMP and rhBMP-2, is unknown. Treating surgeons were unpaid consultants and held shares for Advanced Biologics. However, none of the authors have financial ties to Bioventus, and radiographic fusion was assessed by an independent, blinded radiologist. In the Lumbar Spine Study reported by Roh et al., radiographic assessments for a majority of patients (>70%) in the OSTEOAMP group were based on standard x-ray images while assessment for majority of patients (60%) in the rhBMP-2 group were based on CT images.
The potential limitations of the retrospective foot and ankle study include the following. Retrospective analysis limited by availability of radiographs and medical record data. Radiographic assessments were not blinded. With respect to the larger retrospective chart review, statistical treatment of four patients that were lost-to-follow-up is unknown as is the use of adequate sample sizes to detect differences between OSTEOAMP and “other” graft options.
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