Session I - Polytrauma / Pelvis / Post-Traumatic Reconstruction

Thurs., 10/10/13 Polytrauma/Pelvis/Post-Trauma, PAPER #30, 3:32 pm OTA 2013

The Effectiveness of an Osseointegrated Prosthesis Compared With Socket Prosthesis After Transfemoral Amputation

Henk van de Meent, MD, PhD; Maria Hopman, PhD; Jan Paul M Frölke, MD, PhD;
Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

Purpose: The purpose of this study is to evaluate the functional efficacy of an osseointegrated leg prosthesis (ILP) as compared to conventional sleeve prosthesis.

Methods: In this prospective case-control study, 22 consecutive patients were included after transfemoral amputation (one bilateral) with demonstrable socket-related skin and stump problems resulting in limited prosthetic use. The mean age was 46.5 years (range, 23-67 years) and the mean time after the amputation was 16.4 years (range, 2-45). The cause of amputation was traumatic in 20 and a malignancy in 2 cases. All patients underwent surgical treatment with implantation of an osseointegrated prosthesis (ILP; Ortho Dynamics GmbH, Lubeck, Germany) in two sessions. The primary outcome measure was the validated questionnaire for persons with a transfemoral amputation (Q-TFA) after 1 year. Secondary outcome measures were prosthetic use, 6-minute walking test, timed stand up and go test, and oxygen consumption on the treadmill measured after 1 year.

Results: With a socket prosthesis the Q-TFA showed a mean global score of 38.5 points (standard deviation [SD] 4.7). One year after implantation of the ILP this was 62.6 (SD 5.3). Prosthetic use, the 6-minute walking test, the timed stand up and go test, and oxygen consumption were 55.7 hours per week (SD 7.9), 321 m (SD 28), 15.1 sec (SD 2.1), and 1330 mL/min/kg (SD 310). One year after implantation of the ILP, a significant improvement was registered on all these parameters respectively: 100.9 hours per week (SD 2.4), 423 m (SD 21), 8.1 sec (SD 0.7), and 1093 mL/min/kg (SD 361).

Conclusion: Osseointegration is an effective concept for patients after transfemoral amputation who have complaints from the stump and skin problems. Implantation of an ILP improves their function and quality of life.

Alphabetical Disclosure Listing

• The FDA has not cleared this drug and/or medical device for the use described in this presentation   (i.e., the drug or medical device is being discussed for an “off label” use).  ◆FDA information not available at time of printing. Δ OTA Grant.