Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Study Overview
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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.

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.

Official Title
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Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Conditions
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Lower Limb Amputation

Intervention / Treatment
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* Device: Symphonie Aqua SystemTM
* Procedure: Hand Casting


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, multi-center, assessor-blinded, cross-over study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand Casting<br>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 | Procedure: Hand Casting<br>* plaster of Paris or fiberglass bandages are wrapped around the residual limb<br>|
| Active Comparator: standing hydrostatic pressure casting with a water cylinder<br>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. | Device: Symphonie Aqua SystemTM<br>* a water filled cylinder that can be pressurized around the residual limb to support body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socket Comfort Score | Score from 0-10, with 0 being the least comfortable socket and 10 being the most comfortable socket | at study completion, 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shape capture, prosthetic sockets