H. Michael Mynatt, M.D., orthopedic surgeon at the JRI, is the primary investigator for a multi-center trial to test the safety and effectiveness of the new type of Ceramic-on-Metal IDE Study. This new, large ceramic head hip replacement system is being investigated to see if a combination of ceramic and metal device would benefit patients with a possible improvement in their range of motion.
Dr. H. Michael Mynatt is a diplomat of the American Board of Orthopaedic Surgeons, Associate Clinical Professor Emeritus at the University of Southern California Orthopaedic Department and has served on the medical staff of St. Vincent Medical Center for more than 20 years.
After earning his medical degree from the Medical College of Wisconsin, he completed his internship at the University of California, San Diego. Dr. Mynatt served 2 years of active duty with the U.S. Navy before returning to the Medical College of Wisconsin for orthopaedic residency.
About the Study
Ceramic-on-Metal IDE Study Underway at the Joint Replacement Institute, St. Vincent Medical Center
If you are a candidate for hip replacement, you might be interested in the latest ceramic-on-metal technique. H. Michael Mynatt, M.D., orthopedic surgeon at the Joint Replacement Institute, St. Vincent Medical Center, is the primary investigator for the multi-center trial to test the safety and effectiveness of the new type of implant.
What is the new implant like:
This new, large ceramic head hip replacement system is being investigated to see if a combination of ceramic and metal device would benefit patients with a possible improvement in their range of motion.
What type of patient might qualify:
Mature adults 18 years and older with a need for total hip replacement surgery will be considered if other qualifications for the study are met. All clinical research studies have guidelines about how many patients will be allowed to enter and a detailed description of the qualifications must be reviewed at the Joint Replacement Institute with the research study coordinator and Dr. Mynatt, study doctor.
Where will the surgery take place?
You will be hospitalized during the surgery at St. Vincent Medical Center in Los Angeles, and required to attend outpatient follow-up visits at the Joint Replacement Institute.
Will there be follow-up visits?
If you participate in the study, you will be expected to attend four post-surgical office visits:
• Three (3) months after surgery
• Six (6) months after surgery
• One (1) year after surgery
• Two (2) years after surgery
Thereafter, the FDA may require that the study doctor follows your healing process with follow-up visits once a year for up to 10 years.
Are there any safety guidelines to protect patients who enter clinical research studies?
There are ethical and legal guidelines that the Food and Drug Administration (FDA) has in place for sponsors, study doctors and hospitals to follow. Ethics boards follow federal guidelines that protect and oversee patient safety and personal identity. Your permission or informed consent are required before the study doctor performs any study-related activities.
What are my risks?
Patients should weigh the possible risks and benefits before entering a study. There are risks associated with total hip replacement surgery as well as possible risks of the implant.
What are the benefits?
Some potential benefits that are associated with a clinical research study might include:
• Health care by some of the leading physicians in orthopedics
• Health care that might include more tests than you would normally receive
• Access to new technology that is not available to the general public
• Be part of a group that provides data that might be helpful to others who have similar needs
• Ability to choose another option for medical care
Who is the sponsor of the study?
Wright Medical Technology, Inc.