A clinical trial under way at TIRR Memorial Hermann and UTHealth’s McGovern Medical School is bringing the technique of osseointegration (OI) to the United States, increasing the prosthetic options available to limb-loss patients who are eligible for study participation. Led by physiatrist and amputee specialist Danielle Melton, MD, director of the Limb-loss and Orthotics and Prosthetics Program at TIRR Memorial Hermann, the single-site trial is evaluating the safety and efficacy of Osseo-PL’s Integral Leg Prosthesis for the reconstruction and rehabilitation of trans-femoral amputees.
“Osseointegration has the potential to change the way we treat patients with above-knee amputations who are unable to wear a prosthesis,” says Dr. Melton, a clinical associate professor of orthopedics who specializes in the care of people with amputations. “OI is one of the leading topics today in the limb-loss community, both in the academic medical world and among patients who engage with each other through social media.”
The technique involves attaching an integral leg prosthesis (ILP) directly to the bone, creating a structural and functional connection between living bone and the surface of a load-bearing implant. OI eliminates the need for a socket, the most challenging part of fitting a prosthesis, which in some patients leads to pain and skin breakdown.
“Many limb-loss patients suffer from symptomatic residuum-socket interface problems, which results in reduced prosthetic use and diminished quality of life,” Dr. Melton says. “Over the past two decades, osseointegration has emerged as an attempt to overcome the issues associated with socket-mounted prosthetics. Many people previously unable to use a lower-limb prosthesis, who relied on a wheelchair for mobility, have undergone the procedure successfully and returned to a more active lifestyle.”
Dr. Melton and her team are collaborating with Australian orthopedic surgeon Munjed Al Muderis, MD, whose pioneering work with a high tensile-strength titanium implant of his own design has placed Australia at the forefront of osseointegration. She learned of his work from her patients, many of whom have traveled to Sydney to undergo the procedure.
“We’re partnering with Dr. Al Muderis because his group is strongly focused on the rehabilitation aspect of osseointegration,” she says. “His group includes an entire program with a team approach and a well-established screening process. Candidates for osseointegration are screened using objective measures of general health and mental health, including anxiety and depression. Patients who undergo the procedure stay in Sydney for six weeks of rehabilitation and are followed at six weeks and three, six, nine, 12 and 24 months post surgery. All of my patients who have undergone the procedure are very satisfied – and some are two years out. Eight of my patients have traveled to Australia for the surgery and they’re doing well.”
In late September 2016, Dr. Melton traveled to Australia to attend a daylong program on osseointegration at the Association for the Study and Application of the Methods of Ilizarov (ASAMI) Meeting held in Brisbane, where she was asked to present on the protocol for the U.S. study currently under way. Orthopedic surgeon Matt Koepplinger, D.O., an assistant professor in the department of Orthopedic Surgery at McGovern Medical School, will travel to Sydney in March to undergo training for the procedure.
Dr. Melton’s 24-month study will collect information about the safety and efficacy of the device and its performance to help refine design and develop U.S. regulatory strategy for the ILP. It will also lessen the need for patients to travel to Australia for the procedure.
To be eligible for the trial, patients must be trans-femoral amputees above the age of 18 who are skeletally mature and unable to use a conventional socket-mounted prosthesis. They must be in a generally good state of physical and mental health, and carry sufficient bony stock with adequate muscle strength and range of motion for effective treatment. Exclusion criteria include bone viability, immunosuppression, peripheral vascular disease, diabetes and smoking.
“We’ve had a lot of interest from patients, physicians, prosthetists and institutions around the country,” she says. “We hope our study will lead to a larger pivotal multicenter clinical trial that will pave the way for a broad program of osseointegration in the United States.”
Dr. Melton recently started the Houston Osseointegration Clinic, held quarterly to assess patients appropriate for the study at Memorial Hermann Orthopedic & Spine Hospital at 5420 West Loop South, Suite 2400 in Bellaire, Texas.