The Journal of Foot and Ankle Surgery has published clinical results of Bacterin International Holdings, Inc.’s OsteoSponge SC Allograft that show positive clinical outcomes at two years post-op.
OsteoSponge Improves Ankle Pain and Disability in Study
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Secondary
The study, “Role of Demineralized Allograft Subchondral Bone in the Treatment of Shoulder Lesions of the Talus: Clinical Results with Two-Year Follow-up, ” followed the use of OsteoSponge in the treatment of medial shoulder lesions of the talus. The talus has two “shoulders” which are the outer edges of the talus, a bone in the ankle joint commonly injured as a result of an ankle sprain.
Clinical Outcomes
The article details the clinical outcomes of OsteoSponge to treat medial shoulder lesions of the talus. The study evaluated a retrospective review of 12 adults who had previously failed microfracture, presented with defects of the talus, and underwent a malleolar osteotomy with the use of OsteoSponge SC allograft. A company press release stated, “The results demonstrated statistically significant improvements in pain and disability observed postoperatively within the patient series at 24 months. The one-year post-operative results of this study were published earlier this year in the journal Foot & Ankle Specialist, titled “The Role of Demineralized Allograft Subchondral Bone in the Treatment of Talar Cystic OCD Lesions That Have Failed Microfracture.”
The application of OsteoSponge SC for regeneration of subchondral bone in the talus “represents yet another proven clinical use of this revolutionary bone graft material, ” said Gregory Juda, chief scientific officer for Bacterin. “The simplicity and cost effectiveness of this procedure relative to other available treatment options has the potential to change the way surgeons approach the repair of talar shoulder lesions.”
OsteoSponge SC
OsteoSponge SC is approved as a bone void filler to treat bony defects in the subchondral region of articulating joints.
The OsteoSponge procedure, according to the company, has the potential to address defects associated with subchondral bone pathology, which includes failed microfracture procedures and other treatment modalities. The company estimates the total U.S. market for knee and ankle microfractures in 2014 is approximately 410, 000 procedures. They claim to be the only company in this market with a product specifically positioned to address repair of the subchondral bone in treating these defects, and has demonstrated clinical evidence to support the unique approach.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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