Abstracts Posters SICOT-SOF meeting Gothenburg 2010 _2_

Poster
Topic: Trauma - Femur
Abstract number: 24081
RSA EVALUATION OF AN IMPLANT SYSTEM FOR ABOVE THE KNEE
AMPUTEE PATIENTS
Henrik MALCHAU 1 , Charles BRAGDON 1 , Anne ANTONELLIS 1 , Rickard
BRANEMARK 2
1 Massachusetts General Hospital, Boston (UNITED STATES), 2 Sahlgrenska
Hospital, Goteborg (SWEDEN)
Introduction: Rehabilitation of patients with high, above the knee amputations is
difficult because the standard socket prosthetic devices are difficult or impossible to
use. Development of transdermal osseointregrated devices allowing for the
application of external prosthetic devices is a promising solution for these cases. This
clinical study assesses the fixation of these components in amputee patients using
radiostereometric analysis, (RSA).Methods: Twelve patients with high above the
knee amputations were enrolled into an RSA study. Implanting the Osseointegrated
Prosthesis for the Rehabilitation of Amputees involves a two stage surgical
procedure. The prosthesis is first implanted and the skin incision is closed. Tantalum
beads were placed in the bone and implant. After 6 months, the muscle and skin are
closed around the distal end of the device and a removable prosthetic device is
attached. RSA images were obtained after the second stage, and then at 1 and 2
years.Results: At 1 year the median (std error) proximal/distal migration of the device
was -0.03±0.04mm (range -0.23 to 0.27mm). At 2 years it measured -0.01±0.03 mm
(range -0.16 to 0.15mm). There were no failures. No implant had significant
progressive motion over the two year period.Discussion: The surgical technique for
securing the skin to the implant to avoid skin /implant motion and infection has been
perfected over 10 years. The system is a promising new technique for addressing the
difficult prosthetic challenges faced by patients with high, above the knee
amputations.
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