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Completed

NCT Number: NCT04141748

Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INAIL, Bologna, Emilia-Romagna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Symphonie Aqua SystemTM

Device

a water filled cylinder that can be pressurized around the residual limb to support body weight

Hand Casting

Procedure

plaster of Paris or fiberglass bandages are wrapped around the residual limb

Primary outcomes

  1. Socket Comfort Score

    Time frame: at study completion, 1 month

    Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket

Secondary outcomes

  1. Cast/Socket volume

    Time frame: at every study visit, up to 1 month

    digitized volume and shape of cast and socket

  2. Procedure time

    Time frame: at every study visit, 1 month

    Time to cast, rectify and fit the socket

  3. Socket Fit

    Time frame: at study completion, 1 month

    checklist will be used to assess fit of socket

  4. Socket preference

    Time frame: at study completion, 1 month

    subject's preference for socket to continue wearing

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro)
  • Minneapolis Veterans Affairs Medical Center
  • University of Washington

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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