inMotion Magazine

Being Informed 43 Osseointegration for Patients With Amputation in the United States by Richard J. O’Donnell, MD, and Rickard Brånemark, MD, PhD diseases involving the amputated limb, and use of corticosteroids, chemotherapy or other medications that can interfere with bone healing. Potential patients must be willing and able to comply with a two-stage surgical procedure and a monitored rehabilitation protocol (Figure 5). Patients and prosthetists wishing more information about this study should contact . The OPRA System will also be used as part of the Transfemoral Amputee Osseointegration Study (TFAOS), a joint project between UCSF and the Walter Reed National Military Medical Center. Both institutions are also working together on the Transhumeral Amputee Osseointegration Study (TAOS), using the OPRA above-elbow implant as part of an Investigational Device Exemption (IDE) study allowed by the FDA as of August 14, 2015. Other Approaches The Percutaneous Osseointegrated Prosthesis (POP) System (DJO Global, Vista, California) has been placed in 10 above-knee Veterans Administration patients through an Early Feasibility Study at the University of Utah. Having reached its enrollment goal of 10 patients, this study is presently closed. Zimmer Biomet (Warsaw, Indiana) has adapted Compress ® endoprosthetic (internal prosthesis) limb salvage technology for transdermal (through the skin) applications in amputee patients. As a custom device, this product currently has limited availability; it has reportedly been placed in 17 patients to date. Clinicians in other countries, notably Germany, Australia and the United Kingdom, have sought to develop osseointegrated implants for patients with amputations. To date, none of these devices are available for use within the U.S. Figure 5. The OPRA surgical and rehabilitation protocol. The authors are professors of clinical orthopaedic surgery, University of California, San Francisco (UCSF), and co-directors, UCSF international Center for Osseointegration Research, Education and Surgery (iCORES). Dr. O’Donnell has no conflicts of interest. Dr. Brånemark is a majority shareholder and unpaid board member of Integrum, AB. His spouse is CEO of Integrum, Inc. Association of Brånemark Osseointegration Centers Department of Defense Osseointegration Program Integrum 1 Brånemark R., Berlin Ö., Hagberg K., Bergh P., Gunterberg B., Rydevik B. A Novel Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Study of 51 Patients. The Bone and Joint Journal 2014;96-B:106-113. content/96-B/1/106 Related Resources