Conformis, Inc. Announces Strong Clinical Study Results for Its Personalized Knee Implants
A retrospective review of 540 procedures performed demonstrated 98.5% Implant Survivorship and 89.0% Patient Satisfaction for the Conformis patient-specific iTotal® CR (cruciate-retaining) knee replacement implants at mid-term follow-up
BILLERICA, Mass., September 29, 2021 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS) announced today the strong results of a published retrospective study of procedures using Conformis’ patient-specific iTotal® CR (cruciate-retaining) knee replacement implant, which assessed implant survivorship, patient satisfaction, and functional outcomes.
The primary results of the clinical study include:
- Implant Survivorship – 98.5% – 8 revisions (representing 1.5% of the 540 implants reviewed) at a mean follow-up of 2.8 years (ranging from one month to seven years post surgery)
- Patient Satisfaction – 89% reported being either satisfied or highly satisfied
- Functional Outcomes – high mean score of 82 (range: 34 – 100) using the Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) questionnaire. The study, “Patient Satisfaction, Functional Outcomes, and Implant Survivorship in Patients Undergoing Customized Cruciate-Retaining TKA”, was authored by Dr. Lennart Schroeder, Dr. Cyrus Anthony Pumilia, Dr. Nana O. Sarpong, and Dr. Gregory Martin. It was published online in the September 2021 edition of JBJS (Journal of Bone and Joint Surgery) Reviews.
“This study was one of the largest retrospective studies completed in our history and is another example demonstrating that our technology drives high patient satisfaction, great functional outcomes, and high implant survivorship” said Mark Augusti, President and CEO of Conformis. “This is a strong testament to our entire organization delivering the highest quality products for our customers and their patients. This reinforces our purpose and supports our long-term growth strategy.”
The researchers reviewed patient records and conducted patient report outcome surveys of 540 knees in 433 patients who underwent personalized total knee arthroplasty performed by Dr. Gregory Martin, U.S. board-certified orthopedic surgeon at Personalized Orthopedics of the Palm Beaches in Boynton Beach, Florida. Patient demographics, surgical variables, complications, and re-operations were considered. Follow-up evaluations were performed via a single telephone call to assess survivorship, patient satisfaction, and functional outcomes. At the time of the personalized knee replacement procedure, the mean age of patients studied was 71.8 years and the mean body mass index (BMI) was 29.1 kg/m2 (25-29.9 is the overweight range).
“I am very pleased to see the positive outcomes experienced by my patients who have received Conformis knees,” said Dr. Gregory Martin. “The patient-specific fit and design goal of zero over-hang for iTotal® CR implants contributes greatly to the low percentage of revision procedures needed, high patient satisfaction, and high outcome scores.”
This latest study complements a similar study published in July 2020 by JBJS Reviews, “Patient Satisfaction, Functional Outcomes, and Survivorship in Patients with a Customized Posterior-Stabilized Total Knee Replacement,” which studied similar parameters for Conformis iTotal® PS (posterior-stabilized) knee replacement implant procedures performed by two board-certified U.S. surgeons (Dr. Vivekanand Neginhal of Huntington, West Virginia; and Dr. William Kurtz of Nashville, Tennessee) and had the following results:
- Implant survivorship – 100% at an average follow-up time of 1.9 years;
- Patient Satisfaction – 90% reported being either satisfied or highly satisfied; and
- Functional Outcomes – 90 mean score using the KOOS-JR questionnaire.
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 and conform to each patient’s unique anatomy. Conformis also offers Identity Imprint™, a new line of total knee replacement products that utilizes a proprietary algorithm to select the implant size that most closely meets the geometric and anatomic requirements of the patient’s knee. Conformis’ sterile, just-in-time, Surgery-in-Box™ delivery system is available with all of its implants and personalized, single-use instruments. 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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