Clinical Study Validates the Effectiveness of Conformis’ Fully Personalized Implants (2024)

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Patients preferred the Conformis fully personalized knee compared to a bilateral off-the-shelf knee at a rate of more than 10 to 1.

Image courtesy of Conformis.

About the Study

The study surveyed 47 TKA patients who had a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant in their other knee. The study found that 72.3 percent of the patients studied preferred their fully personalized Conformis knee replacement, compared to 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 study, believed to be the first ever to directly examine patient-reported outcomes comparing fully personalized and traditional off-the-shelf implants in the same patient as a control, underscores the higher levels of satisfaction and lower levels of pain and joint awareness associated with fully personalized implants. The patients reported less pain, better perceived mobility and a more “normal” feeling in the fully personalized Conformis implant.

“This study confirms what the surgeons and engineers working at Conformis have known from the beginning: a fully personalized knee replacement that is designed specifically for each patient’s unique anatomy and original motion clearly contributes to better clinical outcomes and happier patients,” said Mark Augusti, chief executive officer and president of Conformis. “Our fully personalized knee system has demonstrated its clinical benefits in dozens of peer-reviewed studies over the years, and this patient self-controlled research further validates that the patients who are living with two different knee implants can feel the difference. Simply put, our fully personalized implants fit better and feel more natural.”

The patients in the study were evaluated using the Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR), the Forgotten Joint Score (FJS) and preference questionnaire methodologies.

“New technological advances in the past decades have fueled the race for the ‘happiest patient’ following total knee arthroplasty,” wrote the authors. “Patients in this study with bilateral knee joint replacement showed an overall preference for customized total knee arthroplasty.”

“Participants in the present study overall favored the custom total knee arthroplasty (C-TKA) over the standard prostheses in all surveyed categories: pain, motion, stability, ‘normal’ feel, and overall preference,” noted the authors. “On the basis of these findings, the combination of more precise implant fit and component rotation of C-TKA compared with OTS TKA may have been a contributing factor for lower pain levels and functional superiority, thus contributing to patients’ preference for customized over OTS TKA.”

Reference:
^1. Schroeder, Lennart MD1,a; Dunaway, Andrew DO2; Dunaway, Daniel MD3 A Comparison of Clinical Outcomes and Implant Preference of Patients with Bilateral TKA, JBJS Reviews: February 2022 - Volume 10 - Issue 2 - e20.00182 doi: 10.2106/JBJS.RVW.20.00182

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