A Prospective Assessment of an Adjustable, Immediate Fit, Subischial Transfemoral Prosthesis.
Timothy R Dillingham, Jessica L Kenia, Frances S Shofer and 1 others
PMID 36123976WHAT IT FOUND
Eighteen people with transfemoral limb loss rated an adjustable subischial prosthesis significantly better than their conventional socket for comfort and fit after a two-week trial.
Most kept the device, and none reported falls or skin breakdown.
Key findings
01Participants rated the adjustable prosthesis significantly better than their conventional device on the overall satisfaction score.
02The adjustable prosthesis was rated significantly better than the conventional prosthesis on six specific questions regarding volume changes, adjustability, weight, sitting comfort, standing comfort, and standing stability.
03No participants reported falls, skin breakdown, or component failures during the trial.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
The study was a single-site feasibility trial with a small sample size of 18 participants. Participants were not blinded to the device they were wearing, which may have influenced their satisfaction ratings. The questionnaire used was adapted from the Prosthetic Evaluation Questionnaire and has not been fully validated. Knee units were not perfectly matched between the conventional and test devices, though the authors state this did not affect socket scoring. Participants were allowed to keep the prosthesis, which may have introduced bias in their ratings.
Declared interests
The principal investigator and the study team developed the socket design and the offset adapter. The paper lists suppliers for the components but does not explicitly state external funding or commercial conflicts of interest for the authors.
The easy way to misread this
Do not interpret the high satisfaction scores as proof of superior clinical outcomes like reduced energy cost or improved gait mechanics. The study relied on subjective self-reporting from an unblinded, small sample over a short two-week period.