A new, 14-month multi-center study comparing the use of single use extremities instrument kits to standard, traditional implants and instruments, is reporting that physicians may be able to reduce intraoperative time by as much as 33% and realize the attendant, significant savings.
Single Use Extremities Kit Cuts OR Time 33% in New Study
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The study’s lead investigator was John Levin, D.P.M., with Orthopedic Center of Palm Beach, Florida. The study looked at first metatarsal phalangeal joint fusion in 71 patients using sterile instrument kits supplied by Flower Orthopedics, a Horsham, Pennsylvania-based foot and ankle surgical implant and instrument company.
The specific kit was the Midfoot FlowerCube, a single-use, sterile implant and instrument system. Each instrument and implant is Ready-for-Surgery™ and specifically tailored for the metatarsal phalangeal joint fusion. Flower also offers kits for an entire family of procedures.
Dr. Levin, and his study colleagues at the other sites, utilized the kits over a 14-month period from February 2017 to April 2018 in both hospital and ambulatory surgical center settings. In the study, the FlowerCube system was compared to traditional implants.
Patients were followed for 12 weeks post-surgery and assessed with an X-ray to confirm successful fusion at 8 and 12 weeks. The study was managed by JEM Research Institute.
The results of the study were consistent with outcomes reported in prior literature. At eight weeks post-surgery, 84.51% of study patients experienced union of joints. By 12 weeks after surgery, 98.59% of patients experienced union of the joints.
The study concluded that there was a nearly 33% time savings for each case that used the FlowerCube compared to procedures that used traditional implants. This represents nearly 20 minutes time savings for each case. This reduced operating room time means that FlowerCube-based metatarsal phalangeal joint fusions saved approximately $583 per patient, per procedure.
Flower CEO Oliver Burckhardt said, “Flower has long been dedicated to innovative implants and instruments that streamline surgeries and reduce costs of foot and ankle surgeries…. This study further illustrates and quantifies the savings the FlowerCube provides, all while maintaining optimal patient outcomes.”
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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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