Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
Completed · Not applicable
Conditions studied: Lower Limb Amputation
In brief
The overall objective is to compare hand casting to standing hydrostatic pressure casting using a water cylinder in persons with lower limb amputation. Our overall hypothesis is that standing hydrostatic pressure casting with a water cylinder will lead to more consistent and efficient residual limb shape capture and improved initial socket fit and comfort compared to hand casting.
Key facts
- Study ID
- NCT04141748
- Run by
- Northwestern University
- People needed
- 80
- Starts
- 2020-09-01
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- unilateral lower limb amputation (transtibial and transfemoral)
- current prosthesis users
You may not qualify if…
- poor residual limb sensation
- a superficial neuroma that is painful to pressure
- an open sore on the residual limb
- a residual limb circumference or body weight that exceeds the size or weight limits of the Symphonie Aqua SystemTM (i.e., >58cm and 170kg for persons with transtibial amputation and >78cm and 170kg for persons with transfemoral amputation
- persons who are unable to stand for the 4-6 minutes required for casting (e.g. persons with bilateral amputations).
- persons with new amputations (i.e., have been an amputee for less than 1 year)
- persons with transfemoral amputation who have a known silicone allergy or a femur length less than 5 inches
Where it is running
- NUPOC — Chicago, Illinois, United States
- Minneapolis VA Heath Care System — Minneapolis, Minnesota, United States
- INAIL — Bologna, Emilia-Romagna, Italy
Full record on ClinicalTrials.gov
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