Interim U.S. Study Results: ConforMIS’ iTotal CR

By Julie A. Vetalice

Interim results from a U.S. 300+ patient multi-center prospective study of ConforMIS' (CFMS) iTotal CR total knee indicate that 92% of patients were satisfied, on average, at one year.

This compares to results of a 2009 1,700-patient study indicating that ~20% of patients receiving an off-the-shelf total knee are not satisfied with the results.

The new analysis corroborates a previously-published study demonstrating statistically significantly higher satisfaction rates with iTotal CR vs. off-the-shelf implants in 35 matched pairs of subjects. At one year, 94% of iTotal patients vs. 74% of off-the-shelf patients reported satisfaction with their procedure.

In 1Q16, CFMS announced study results comparing iTotal CR vs. a Zimmer Biomet NexGen® ("Legacy") or Persona® ("Modern") total knee (25 patients with iTotal CR, 15 with a Legacy implant and 19 patients with a Modern implant).

Sources: ConforMIS, Inc.; Clinical Orthopaedics and Related Research; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: Trial/Study