Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-09-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lower Limb Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective, multi-center, assessor-blinded, cross-over study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Hand Casting

Intervention Type PROCEDURE

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

standing hydrostatic pressure casting with a water cylinder

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.

Group Type ACTIVE_COMPARATOR

Symphonie Aqua SystemTM

Intervention Type DEVICE

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

Interventions

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Symphonie Aqua SystemTM

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

Intervention Type DEVICE

Hand Casting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No