Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Lower Limb Amputation Clinical Trial

Official title:

Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141748
• Other study ID #: W81XWH1910835
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation

Intervention

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

Locations

Country	Name	City	State
Italy	INAIL	Bologna	Emilia-Romagna
United States	NUPOC	Chicago	Illinois
United States	Minneapolis VA Heath Care System	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	INAIL (Istituto Nazionale per L'Assicurazioni contro gli Infortune sul Lavoro), Minneapolis Veterans Affairs Medical Center, University of Washington

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

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