Sunday, November 27, 2022

Conformis Highlights New Clinical Study Findings

Findings Show That Knee Shapes are Highly Individualized and are Not Determined by Identifiers, Including Gender, Body Type, or Ethnicity

Conformis, Inc. today announced the results of a published study that investigated the characteristic shapes of knees to see if typical patient identifiers such as gender, body type, or ethnicity influence the shape of the knee joint.

The study, published in The Knee1, found that knee shape occurs independently from characteristics typically used to identify patients.

The study also found that identifiers, such as gender, body type, and ethnicity do not help surgeons determine which off-the-shelf replacement system or implant size will best fit each individual. This recent clinical study further underscores the value of precisely matching a replacement joint with the specific anatomy of each patient.

The absence of predictable shapes or morphotypes “makes it difficult to further reduce the bone to implant mismatch with off-the-shelf implants,” note the authors. Trying to do so, they say, might require an excessive number of sizes of standardized implants that provides significant logistical challenges for facilities. An alternative, they conclude, is the use of customized implants using “patient-specific implant design.”

Led by Benjamin Hohlmann and Malte Asseln of the Helmholtz Institute for Biomedical Engineering at Aachen University in Germany, the authors conducted their analysis using a data set of computed tomography images from more than 1,000 pathological knees provided by Conformis. Conformis also shared in the funding for this study.

“This new research reinforces the importance of precisely matching the implant to the individual patient,” said Mark Augusti, Chief Executive Officer and President of Conformis. “This is only possible with a patient-specific implant system available through our Platinum Services Program, such as our fully personalized Identity knee system. This study further supports our long-held business case that fully personalized implants provide the best fit for patients, eliminate clinically-significant overhang, minimize post-operative pain, speed recovery time, and enhance flexibility and performance.”

The authors used two different methodologies to analyze the knee images in an effort to find “clusters” of knees that could provide a way to standardize knee design based on patients’ gender, body type, ethnicity, or other characteristics like age. As expected, the data did not generate any clusters that could be used as predictors to better fit of off-the-shelf implants to the specific anatomies of patients undergoing total knee arthroplasty (TKA).

The article in The Knee follows a retrospective study published in The Journal of Bone & Joint Surgery Reviews (JBJS Reviews2), announced by Conformis on February 28, 2022, which found that patients who had undergone TKA surgery preferred their Conformis fully personalized knee compared to their bilateral off-the-shelf knee at a rate of more than 10 to 1.

That earlier study compared patients who had a fully personalized Conformis implant in one knee after receiving a competitive off-the-shelf implant in the other knee, and found that 72.3 percent of the patients studied preferred their fully personalized Conformis knee replacement, compared to only 6.4 percent of patients who preferred their traditional off-the-shelf (OTS) implant. The remaining 21.3 percent reported no perceived difference between the two knee implants.

The authors of the new study concluded, “The data exhibited no morphotypes. This showed that there are no relevant identifiers, e.g., gender, body type, or ethnicity which influence the shape of the knee joint. Instead, knee shape is determined by the unique characteristics of each individual.”

Conformis has been a leader in patient specific technology since its founding in 2004. The company continues to innovate and make significant advances for surgeons and patients alike. Most recently, Conformis launched the Image-to-Implant® Platinum Services℠ Program, the first deluxe personalization upgrade services program in the orthopedic market.

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