90% Patient Satisfaction Reported in Peer-Reviewed Clinical Study of Conformis iTotal PS Knee Replacements
Clinical research published online in July 2020 in The Journal of Bone and Joint Surgery Reviews found that the patients studied, who all received Conformis patient-specific iTotal PS (posterior-stabilized) knee replacement implants, were 90% satisfied, or very satisfied, 18–28 months post-surgery.
BILLERICA, Mass., August 10, 2020 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS) announced today that 90% of the patients studied in peer-reviewed clinical research published online in The Journal of Bone and Joint Surgery Reviews were satisfied, or very satisfied, 18–28 months post-surgery. In addition, 88% of patients reported that their knees felt natural either some or all of the time.
The clinical study, conducted by renowned U.S. orthopedic surgeons Vivekanand Neginhal and William Kurtz, and researcher Lennart Schroeder, was designed to test the hypothesis that the Conformis PS implant would drive high overall patient-reported outcomes because of its patient-specific design. Further details on the research, cited here, may be found online at the URL below:
Neginhal, Vivekanand MD; Kurtz, William MD; Schroeder, Lennart MD Patient Satisfaction, Functional Outcomes, and Survivorship in Patients with a Customized Posterior-Stabilized Total Knee Replacement, JBJS Reviews: July 2020 – Volume 8 – Issue 7 – p e19.00104 doi: 10.2106/JBJS.RVW.19.00104
“This peer-reviewed clinical research is the latest in more than thirty studies published in medical journals that supports the strong performance of our patient-specific implants, which are designed to fit each patient’s unique anatomy,” said Mark Augusti, President and Chief Executive Officer. “While market research generally indicates that knee replacement with traditional knee implants fails to satisfy 20–30% of patients, we are pleased to once again see that our technology is a major contributor to much higher patient satisfaction, an end to chronic pain, and restoration of mobility.”
In addition to patient satisfaction rates, patient-reported outcomes were assessed utilizing the Knee injury and Osteoarthritis Outcome Score Joint Replacement (KOOS JR). KOOS JR interval scores range from 0 (total knee disability) to 100 (perfect knee health), and the average score for the patients studied was 90.
The researchers also found that the average preoperative baseline pain rating of 6.5 (range of 3 to 10) for the patients studied decreased by 5.2 on the numeric pain rating scale to an average of 1.3 (range of 0 to 8), which reflects a dramatic reduction in pain.
The final measure assessed was implant survivorship, which was found to be 100% at an average of 23 months post-op for the 100 knees included in the study.
About Conformis, Inc.
Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants and instruments that are individually sized and shaped, which we refer to as personalized, individualized, or sometimes as customized, to fit each patient’s unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals and ambulatory surgical centers. In clinical studies, the Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.
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