NCT04141748

Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Limb Amputation

Interventions

Type	Name	Description
DEVICE	Symphonie Aqua SystemTM	a water filled cylinder that can be pressurized around the residual limb to support body weight
PROCEDURE	Hand Casting	plaster of Paris or fiberglass bandages are wrapped around the residual limb

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2019-10-28
• Last updated: 2024-09-19

Locations

3 sites across 2 countries: United States, Italy