Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Last updated: September 16, 2024
Sponsor: Northwestern University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Hand Casting

Symphonie Aqua SystemTM

Clinical Study ID

NCT04141748
W81XWH1910835
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • unilateral lower limb amputation (transtibial and transfemoral)

  • current prosthesis users

Exclusion

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 limitsof the Symphonie Aqua SystemTM (i.e., >58cm and 170kg for persons with transtibialamputation 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 femurlength less than 5 inches

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Hand Casting
Phase:
Study Start date:
September 01, 2020
Estimated Completion Date:
September 01, 2023

Study 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.

Connect with a study center

  • INAIL

    Bologna, Emilia-Romagna 40139
    Italy

    Site Not Available

  • NUPOC

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Minneapolis VA Heath Care System

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

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