VA Osseointegration Study
Full name: CSP #2017: Pivotal study to characterize the efficacy and safety of a percutaneous osseointegrated prosthesis
Background
Osseointegration is a surgical technique that allows for direct attachment of prosthetic devices to the skeleton of patients with amputations. The device is connected to the remaining bone of the amputated limb and extends through an opening in the skin to connect to the prosthesis. VA has recently started to offer osseointegration to some Veterans with amputations. Dr. Shereef Elnahal, Under Secretary of Veterans Affairs for Health, published a podcast on osseointegration, which includes interviews from some Veterans that have undergone the surgery. His New Horizons in Health podcast can be found here: New Horizons in Health – Episode 6: Osseointegrated Prosthetics
The Percutaneous Osseointegrated Prosthesis (POP) is a novel device that is implanted into the femur (thigh bone) of Veterans with above-knee-amputations (AKA). The POP device allows for the direct skeletal attachment of a prosthetic leg. Compared to traditional socket suspension techniques for prosthetic limbs, direct skeletal attachment may offer many potential advantages for patients with amputations. VA and its partners are currently investigating the potential advantages of the POP device in a clinical study.
This study will be a multi-year, multi-site clinical trial that aims to determine whether the POP device is a safe and effective alternative to the traditional socket-type prosthesis. The study, CSP #2017, will enroll Veterans nationwide between 2025 and 2029.
Study Details
Veterans with above the knee amputations are eligible to participate. The surgeries will take place at six VA Medical Centers across the county. The procedure consists of two separate surgeries and Veterans will need to travel to one of the surgical sites for all study activities. Travel costs will be provided by the VA.
We anticipate that Veteran participation in the study will last approximately 2-3 years. Please contact us using the telephone number below to find out more about the study.
Contact Us
Veterans interested in learning more about the study are encouraged to call 1-833-412-9359.
