Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Not Applicable

Completed

• Conditions: Lower Limb Amputation
• Interventions: Procedure: Hand Casting; Device: Symphonie Aqua SystemTM

• Registration Number: NCT04141748
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

One of the most important components of restoring function in persons with lower limb amputation is the precise fitting of the prosthetic socket to the residual limb. However, this is challenging because the residual limb is dynamic in shape and volume. Additionally, prosthetic socket fabrication processes influence socket fit. These processes typically consist of residual limb shape capture, positive mold rectification, initial diagnostic socket fitting, and definitive prosthesis delivery. The most prevalent residual limb shape capture method involves a negative wrap cast in a non-weight bearing position and manual manipulation of the cast to conform to the residual limb shape. With this technique it is challenging to accurately capture the bony contours and distribute pressure evenly around the residual limb. To improve shape capture, techniques that rely less on manual manipulation by the prosthetist, such as standing hydrostatic pressure casting with a water cylinder have been developed. Given the use of physics to shape the residual limb, it has been proposed that pressure casting results in better fitting and more comfortable sockets, however this has not yet been demonstrated. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2020-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• unilateral lower limb amputation (transtibial and transfemoral)
• current prosthesis users

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hand Casting	Hand Casting	hand cast will be taken using a circumferential plaster of Paris or fiber glass wrap of the residual limb with the subject in a seated position
standing hydrostatic pressure casting with a water cylinder	Symphonie Aqua SystemTM	hand cast will be taken using a circumferential plaster of Paris wrap of the residual limb with the subject in a seated position. The residual limb is then placed into the Symphonie Aqua System while in a weight bearing standing position.

Primary Outcome Measures

Name	Time	Method
Socket Comfort Score	at study completion, 1 month	Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket

Secondary Outcome Measures

Name	Time	Method
Procedure time	at every study visit, 1 month	Time to cast, rectify and fit the socket
Cast/Socket volume	at every study visit, up to 1 month	digitized volume and shape of cast and socket
Socket Fit	at study completion, 1 month	checklist will be used to assess fit of socket
Socket preference	at study completion, 1 month	subject's preference for socket to continue wearing

Trial Locations

Locations (3)

NUPOC; 🇺🇸 Chicago, Illinois, United States

Minneapolis VA Heath Care System; 🇺🇸 Minneapolis, Minnesota, United States

INAIL; 🇮🇹 Bologna, Emilia-Romagna, Italy