ConforMIS yesterday announced the results from 6 clinical studies of its iTotal CR knee replacement at the 2015 Pan Pacific International Congress for Joint Reconstruction.
One ongoing 295-patient study reported that patients treated with the iTotal CR knee replacement were 170% more likely to have excellent or good Knee Society Scores, according to the company.
A separate functional test administered during the study found that patients treated with ConforMIS’ knee replacement had statistically better Aggregated Locomotor Function scores and showed significantly faster walking speed than those treated with off-the-shelf replacements.
“After performing several thousand total knee replacements, I have seen firsthand that using a customized implant designed specifically for each patient could have a significant impact on restoring function and improving overall patient satisfaction and ability to perform daily activities. This new data provides additional clinical evidence demonstrating that customized knee implants can deliver measurable advantages for patients that have a direct and positive impact on patient quality of life,” lead investigator Dr. Robert Tait of Henderson, Nev.’s St. Rose Dominican Hospital Siena said in a prepared statement.
A 252-patient study of the iTotal CR replacement showed high patient-reported outcome scores, high range of motion, short hospital stays and excellent safety profiles, the company said.
Two other studies used real-time x-ray imaging and mobile fluoroscopy to study movement and kinematics of the replacement. The studies observed knee motion more consistent with normal knee movement and less implant lift-off in early flexion in patients treated with ConforMIS’ replacement versus an off-the-shelf replacement, ConforMIS said.
“Previous clinical studies have shown that about 20% of patients who receive a total knee replacement are not satisfied with the results. By focusing on the patient and specifically each patient’s unique anatomy, we believe ConforMIS is transforming the knee replacement experience for patients. By designing implants to match the fit and natural curves of each patient’s knee, we believe our iTotal CR, iUni and iDuo knee replacements can provide patients with improved functional outcomes and higher overall satisfaction levels,” CEO Dr. Philipp Lang said in a press release.