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Format: 04/18/2014
Format: 04/18/2014

News

Forbes Regional Hospital Tests Personalized Implants for Partial Knee Replacement

Friday, May 6th, 2011

Orthopaedic surgeons at the Joint and Spine Center at Forbes Hospital are studying the long-term effectiveness of customized knee implants designed to correct damage from osteoarthritis.

The ConforMIS iUni G2 knee resurfacing device was approved by the US Food and Drug Administration for use in patients with osteoarthritic damage in a single compartment of the knee. Unlike traditional total knee replacement which replaces the entire joint, this partial knee resurfacing device allows for the targeted and minimally invasive treatment of just the diseased area of the knee in properly indicated patients.

Through a recently formed a partnership with the Allegheny Singer Research Institute (ASRI), Forbes is now participating in a 10-year follow-up trial to gather information on the function and durability of pain relief from the iUni G2 implant. 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.

In addition to a more targeted treatment approach, the iUni G2 uses advanced computer modeling and the latest manufacturing technology to provide an individually-designed and manufactured implant for each patient. Using CT scans of the patient’s knee, each implant has a shape and size that is 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.

“We are excited to participate in the iUni trial to evaluate the long-term performance of this customized approach to unicompartmental knee replacement in treating osteoarthritis,” said Dr. Michael Levine, Principal Investigator of the clinical trial at Forbes Hospital. “We believe the personalized approach of this device will demonstrate and deliver long-term benefits to our patients.”

The iUni G2 trial will enroll adult patients whose doctors have recommended a unicompartmental knee implant due to osteoarthritis. Potential participants will receive a baseline assessment to determine their eligibility for the study as well as questionnaires about symptoms and quality of life.

Those selected for participation 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, for a period of five years. After that, investigators will conduct follow-up interviews once a year via telephone or e-mail for 10 years after the procedure.
For more information about the trial, visit www.clinicaltrials.gov or call 412-373-1600.

ConforMIS, Inc. is a privately-held company that develops medical devices and surgical techniques for treating osteoarthritis and joint damage. In 2009, ConforMIS received a Medical Design Excellence Award, the premier recognition for contributions and advances in the design of medical products, for its resurfacing implants.

The Joint and Spine Center at Forbes Hospital combines state-of-the-art orthopaedic and neurosurgical care with a treatment model that focuses on the patient, not the procedure. This patient-centered philosophy supports rapid recovery in an environment of camaraderie and individual attention. Center staff share their expertise in a team approach, delivering the highest quality of care in a convenient, suburban location.

Allegheny Singer Research Institute, the research arm of the West Penn Allegheny Health System, has been managing and conducting research for 34 years. Forbes’ partnership with ASRI will open the door to a significant growth in medical research at the hospital, offering many more opportunities for people in the Monroeville community to access state-of-the-art medical care in the future.

”Through our affiliated network of community hospitals, such as Forbes Hospital, we are able to expand considerably the geographic and demographic reach of our System’s research capabilities. These outstanding hospitals and their physicians are well respected and trusted in the communities they serve and as such tend to be very successful in recruiting patients to important clinical studies,” said Joseph Ahearn, MD, ASRI’s Chief Scientific Officer and Vice President of Research and Development.

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