A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation

Abstract

Patients with transfemoral amputation (TFA) often experience problems related to the use of socket-suspended prostheses. The clinical development of osseointegrated percutaneous prostheses for patients with a TFA started in 1990, based on the long-term successful results of osseointegrated dental implants. Between 1999 and 2007, 51 patients with 55 TFAs were consecutively enrolled in a prospective, single-centre non-randomised study and followed for two years. The indication for amputation was trauma in 33 patients (65%) and tumour in 12 (24%). A two-stage surgical procedure was used to introduce a percutaneous implant to which an external amputation prosthesis was attached. The assessment of outcome included the use of two self-report questionnaires, the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) and the Short-Form (SF)-36. The cumulative survival at two years' follow-up was 92%. The Q-TFA showed improved prosthetic use, mobility, global situation and fewer problems (all p < 0.001). The physical function SF-36 scores were also improved (p < 0.001). Superficial infection was the most frequent complication, occurring 41 times in 28 patients (rate of infection 54.9%). Most were treated effectively with oral antibiotics. The implant was removed in four patients because of loosening (three aseptic, one infection). Osseointegrated percutaneous implants constitute a novel form of treatment for patients with TFA. The high cumulative survival rate at two years (92%) combined with enhanced prosthetic use and mobility, fewer problems and improved quality of life, supports the 'revolutionary change' that patients with TFA have reported following treatment with osseointegrated percutaneous prostheses.

Osseointegrated total knee replacement connected to a lower limb prosthesis: 4 cases

“…A superficial infection was treated with a single 7-day course of oral antibiotics (cephalexin 500 mg). The few authors who have reported on the safety of osseointegrated implants have described an acceptable rate of superficial infection and rare occurrence of other adverse events, including deep infection (Brånemark et al 2014). Altogether, one could hypothesize that the absence of stoma revision and explantation surgeries might be due to techniques adopted to close pathways from the external environment, such as press-fit implantation and soft tissue handling, consequently sealing the knee to ascending infections.…”

“…Few authors have reported on the safety of this procedure (Brånemark et al 2014, Tsikandylakis et al 2014). One of the largest studies included 51 patients and reported superficial infections in approximately half of these patients at 2-year follow-up.…”

“…One of the largest studies included 51 patients and reported superficial infections in approximately half of these patients at 2-year follow-up. In that study, the implant was removed in 1 patient due to deep infection and in 3 patients due to aseptic loosening (Brånemark et al 2014). …”

From Bench to Bedside: A Perfect Fit? Osseointegration Can Improve Function for Patients with Amputations

“…Rickard developed a textured long-bone fixture modified from his father's dental screw design and began an osseointegration program for those with limb loss in Sweden in the 1990s [3]. Subsequently, Horst Aschoff in Germany developed a press-fit implant for transcutaneous osseointegration [2].…”

“…Most importantly, patient comfort can be dramatically improved by obviating socket related problems and residual limb pain. Aseptic loosening (2%-6%) and periprosthetic fracture (0%-4%) have occurred at relatively low and ostensibly acceptable rates [2,3,6,9]. However, concerns regarding infection by way of the skin-implant interface persist.…”