Study Results: Conformis iTotal CR Knee

By Julie A. Vetalice

Study Results: Conformis iTotal CR Knee

Conformis announced 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 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).

This latest study complements a similar study published in 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.

Source: Conformis, Inc.

Product Labels: Knee Replacement

Tags: Trial/Study