Researchers at Arkansas Specialty Orthopedics will participate in a 10-year follow-up trial of the ConforMIS iUni G2 knee resurfacing device, an FDA-approved implant for patients with osteoarthritic damage in a single compartment of the knee.
Unlike a traditional knee replacement which replaces the entire joint, the ConforMIS partial knee resurfacing device allows for the targeted and minimally invasive treatment of just the diseased area of the knee in properly indicated patients.
The iUni G2 uses computer modeling and manufacturing technology to provide an individually designed implant. Using CT scans of a patient’s knee, each implant has a shape and size based on the patient’s own anatomy. The personalized shape and fit allows for greater bone and tissue preservation and the potential for more natural knee motion, in addition to a faster recovery than traditional total knee replacement.
The post-market trial involves patient screening and assessment to determine eligibility; a surgical procedure to implant the device; follow-up visits at the clinic; and long-term monitoring to gather information on the function and durability of pain relief from the implant.
“We are pleased to be part of the iUni trial, which will evaluate the long-term performance of this new customized approach to unicompartmental knee replacement in treating osteoarthritis,” said C. Lowry Barnes, MD, principal investigator of the trial.
The iUni G2 trial will enroll adult patients whose doctors have recommended a unicompartmental knee implant due to osteoarthritis.
Participants will receive a baseline assessment to determine eligibility for the study, as well as questionnaires about symptoms and quality of life. Those determined ineligible will have the opportunity to discuss alternatives with their doctors. Those selected will undergo surgery to implant a custom iUni G2, and then be required to return to the clinic for follow-up assessments, including questionnaires and X-rays.