Metal on Metal Total Hip Prostheses

James C. Kudrna, MD, PhD, Clinical Professor for Northwestern University and Orthopaedic surgeon for Illinois Bone and Joint Institute has begun clinical trails on the S-ROM®, Summit®, and Pinnacle® metal-on-metal total hip prostheses (DePuy Orthopaedics, Warsaw, Indiana). Metal-on-metal total hip prostheses have been re-introduced as an alternative bearing system to metal-on-polyethylene (a plastic material that has been the standard for over 20 years).

The objective of ongoing total hip arthroplasty component design modifications has been to reduce products of wear so to eliminate osteolysis and loosening which leads to revision surgery. Although wear particle-induced osteolysis may depend on multiple factors including particle shape, size, and composition, it generally is regarded as being dose-dependant. Therefore, a major reduction in volumetric wear may be of tremendous potential clinical benefit. The desire to eliminate polyethylene debris has fueled research and development of alternative bearing surfaces such as ceramics and metal-on-metal.

These clinical trials include patients with a diagnosis of osteoarthritis between the ages of 45 and 65 requiring a primary total hip arthroplasty. Patients who pass certain inclusion criteria (for example: no other metal implants) are eligible to volunteer. Enrolled patients will be required to donate blood and urine during a pre-

operative evaluation, and also during follow-up evaluations at 3 months, 1 year, 2 years, and 3 years after their surgery. This research is focused on detecting, measuring and tracking the levels of metal ions in the blood and urine of patients receiving their first prosthesis coupled with either a metal or plastic socket.

If you think you might be interested in participating in Dr. Kudrna’s clinical research studies to evaluate metal-on-metal total hip prostheses, please contact Dr. Kudrna or his Research Coordinator, Valerie Harder, at 847-998-5680, for further details.

Please note: Your request for more information about this study does not commit you to participate. In order to participate, you will have to sign a consent form detailing the study, the prosthesis, and the risks associated with total hip arthroplasty. The FDA has already approved all implants utilized in these clinical trials. All data resulting from analyses of patient blood and urine will be collected and stored in a database developed exclusively for this research project. Please know that Illinois Bone and Joint Institute takes your privacy very seriously. All information will be used for Illinois Bone and Joint Institute’s research purposes only and is strictly confidential.