The first FDA approved modular system for dealing with two-stage revisions of infected hip and knee arthroplasty is produced and distributed by OsteoRemedies, LLC, of Memphis, Tennessee. Called the Remedy Spacer, the device is a sterile-packaged, pre-formed, pre-loaded spacer dosed with Gentamicin antibiotics which its distributor claims will provide a consistent and reliable elution to the infected joint spaces.
Hip/Knee Infection Fighting System Gets FDA Approval
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When combined with a consistent process for polishing the articulating surfaces, the Remedy spacer is approved for temporary use for up to 180 days.
Proponents say that the system enables surgeons to address a patients’ anatomy with complete interchangeability between femoral and tibial knee sizing for those revisions and a full modular femoral head and stem design for hip revisions. As a packaged solution the Remedy spacer is claimed to save time for the surgeon and the hospital when compared to traditional revision infection procedures.
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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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