Clinical Evidence

Bioventus Surgical supports the creation of clinical evidence through company sponsored and investigator initiated studies. We have several ongoing studies in support of products in our portfolio.

Study Name
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OSTEOAMP Foot and Ankle Arthrodesis – DeVries et al.

OSTEOAMP vs. Infuse® Lumbar Interbody Fusion Retrospective - Roh et al. Bioventus Tooltip

OSTEOAMP Cervical Fusion Retrospective - Field et al. Bioventus Tooltip

OSTEOAMP Clinical Efficacy Validation - Yeung et al. Bioventus Tooltip

New and Ongoing Clinical Trials

We have an ongoing prospective PLF study currently evaluating the safety and effectiveness of OSTEOAMP.

Investigator Initiated Study

If you are interested in conducting your own clinical evaluation, you are welcome to submit a request for funding.

Study Limitations

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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