A scoring system to evaluate stability of percutaneous osseointegrated implants for transfemoral amputation with validation in the ITAP clinical trial.

Percutaneous osseointegrated implants for individuals with lower limb amputation can increase mobility, reduce socket related pain, and improve quality of life. It would be useful to have an evaluation method to assess the interface between bone and implant. We assessed outpatient radiographs from the Intraosseous Transcutaneous Amputation Prosthesis clinical trial using an interface scoring system which summed and weighted equally measures of implant collar cortical ongrowth and radiolucency along the implant stem/bone interface. Radiographs from 12 participants with unilateral transfemoral amputations (10 males, 2 females, mean age = 43.2, SD = 7.4 years) in the clinical trial from cohort I (implanted in 2008/09) or cohort II (implanted in 2013/14) were collated (mean image span = 7.2, SD = 2.4 years), scale normalised, zoned, and measured in a repeatable way. Interface scores were calculated and then compared to clinical outcomes. Explanted participants received the lowest interface scores. A higher ratio of stem to residuum and shorter residuum's produced better interface scores and there was an association (weak correlation) between participants with thin cortices and the lowest interface scores. A tapered, cemented, non curved stem may provide advantageous fixation while stem alignment did not appear critical. In summary, the interface score successfully demonstrated a non-invasive evaluation of percutaneous osseointegrated implants interfaces when applied to the Intraosseous Transcutaneous Amputation Prosthesis clinical trial. The clinical significance of this work is to identify events leading to aseptic or septic implant removal and contribute to clinical guidelines for monitoring rehabilitation, design and surgical fixation choices.