Background: Percutaneous osseointegrated devices for skeletal fixation of prosthetic limbs have the potential to improve clinical outcomes in the transhumeral amputee population. Initial endoprosthesis stability is paramount for long-term osseointegration and safe clinical introduction of this technology. We evaluated an endoprosthetic design featuring a distally porous coated titanium stem with proximal slots for placement of bicortical interlocking screws.
Methods: Yield load, ultimate failure load, and construct stiffness were measured in 18 pairs of fresh-frozen and thawed cadaver humeri, at distal and proximal amputation levels, without and with screws, under axial pull-out, torsion, and bending loads. Paired statistical comparisons were performed without screws at the two resection levels, and at distal and proximal levels with and without screws.
Findings: Without screws, the location of the amputation influenced the stability only in torsional yield (p = 0.032) and torsional ultimate failure (p = 0.033). Proximally, the torsional yield and the torsional ultimate failure were 44% and 47% of that distally. Screws improved stability. In axial pull-out, screws increased the distal ultimate failure 3.2 times (p = 0.003). In torsion, screws increased the yield at the proximal level 1.9 times (p = 0.035), distal ultimate failure load 3.3 times (p = 0.016) and proximal ultimate failure 6.4 times (p = 0.013). In bending, screws increased ultimate failure at the proximal level 1.6 times (p = 0.026).
Interpretation: Proximal slots and bicortical interlocking screws may find application in percutaneous osseointegrated devices for patients with amputations, especially in the less stable proximal bone of a short residual limb.
Keywords: Amputation; Humerus; Implant; Osseointegration; Screw.
Copyright © 2019. Published by Elsevier Ltd.