Background: Techniques for the skeletal attachment of amputation-prostheses have been developed over recent decades. This type of attachment has only been performed on a small number of patients. It poses various potential advantages compared to conventional treatment with a socket, but is also associated with an increased risk of bone or implant-bone interface fracture in the case of a fall. We therefore investigated the bending stiffness and ultimate bending moment of such devices implanted in human and synthetic bones.
Methods: Eight human specimens and 16 synthetic models of the proximal femora were implanted with lower extremity prostheses and eight human specimens and six synthetic humeri were implanted with upper extremity prostheses. They were dissected according to typical amputation levels and underwent loading in a material testing machine in a four-point bending setup. Bending stiffness, ultimate bending moment and fracture modes were determined in a load to failure experiment. Additionally, axial pull-out was performed on eight synthetic specimens of the lower extremity.
Results: Maximum bending moment of the synthetic femora was 160.6±27.5 Nm, the flexural rigidity of the synthetic femora was 189.0±22.6 Nm2. Maximum bending moment of the human femora was 100.4±38.5 Nm, and the flexural rigidity was 137.8±29.4 Nm2. The maximum bending moment of the six synthetic humeri was 104.9±19.0 Nm, and the flexural rigidity was 63.7±3.6 Nm2. For the human humeri the maximum bending moment was 36.7±11.0 Nm, and the flexural rigidity at was 43.7±10.5 Nm2. The maximum pull-out force for the eight synthetic femora was 3571±919 N.
Conclusion: Significant differences were found between human and synthetic specimens of the lower and upper extremity regarding maximum bending moment, bending displacement and flexural rigidity. The results of this study are relevant with respect to previous finding regarding the load at the interfaces of osseointegrated prosthesis fixation devices and are crucial for the development of safety devices intended to protect the bone-implant interface from damaging loadings.