Osseoperception in transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation: a prospective study.

Background: Endo-exo prosthetics (EEP), which belongs to the transcutaneous osseointegrated prosthetic systems (TOPS), provides an alternative bone-anchored rehabilitation method for transfemoral amputees. It led to the question of whether transmitted forces from prosthetic feet are perceptible by osseoperception resulting in proprioceptive feedback of ground conditions.

Objectives: The following hypotheses emerged for our trial with the null hypothesis: EEP fitting after transfemoral amputation does not influence osseoperception. Alternative hypothesis 1: EEP patients achieve better osseoperception results than transfemoral amputees fitted with socket prosthesis. Alternative hypothesis 2: EEP carriers achieve comparable results with regards to their osseoperception as non-amputees.

Methods: N = 25 patients with EEP (mean age = 50,6 ± 9,4, male/female = 15/10) N = 25 patients with socket prostheses (mean age = 52,6 ± 13,1, male/female = 19/6) and N = 25 healthy volunteers were included in the experimental case-control study. In three blinded test modules (V1, V2, V3), the participants had to identify different degrees of shore hardness (c) of different materials (rubber balls (shore = 5-25c), foam cushions (shore = 5-30c), foam mats (shore = 5-30c) with their prosthetic foot (or a personally defined foot in healthy volunteers) without footwear and had to rank them into the correct order according to their tactile sensation and the degree of hardness. A maximum of 10 points could be scored per run.

Results: This experimental observational study included N = 75 participants. The mean age for the entire cohort was 42.8 ± 16.6 years and the BMI was 26.0 ± 4.8. Our results show a significant level of differences in tactile osseoperception between all groups (p < 0.001). A correlation between the mean values of V1-3 and the PMQ2.0 as well as the mean values of K-Level and the prosthesis wearing time per day showed for PMQ (r = 0.387, p = 0.006) and K-level (r = 0.448, p = 0.001) which is a moderate effect according to Cohen.

Conclusion: Our study results suggest that the EEP treatment can lead to an improvement in tactile sensory perception via the bone-anchored implant, which can lead to an increase in quality of life and improved gait safety.