NCT04155762

Effects of Pin and Vacuum Assisted Suspension Systems

Completed NA Last updated 12 November 2019

What this trial tests

NA trial testing Pin Suspension System (a prosthetic suspension system) in Amputees in 9 participants. Completed in 1 February 2019.

Timeline

1 February 2015

Primary endpoint
1 February 2017

1 February 2019

Quick facts

Lead sponsor	Baskent University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	9
Start date	1 February 2015
Primary completion	1 February 2017
Estimated completion	1 February 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Pin Suspension System (a prosthetic suspension system)
• Vacuum-Assisted Suspension System (a prosthetic suspension system)

Conditions studied

• Amputees — all drugs for Amputees →
• Prosthesis User — all drugs for Prosthesis User →
• Artificial Limbs — all drugs for Artificial Limbs →

Sponsor

Baskent University

Who can join

Adults 18 to 65, any sex, with Amputees or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was performed to determine the presence of any difference between Pin Suspension (PS) and Active Vacuum Suspension (AVS) on walking capacity, functional mobility, weight bearing in the prosthetic side, prosthetic satisfaction and body image were evaluated. Nine patients who don't have an obstacle to both socket applications in terms of stump height, type and edema were evaluated in this study. Both suspension systems were administered to the patients included in the study. First, amputees have used PS for 3 months following alignment of the prosthesis and training period. Then again they used AVS for 3 months following alignment of the prosthesis and training period. For each system, after adapting prosthesis 'LASAR posture' was used to evaluate weight bearing on the prosthetic side, '6 Minute Walk Test' for walking capacity, 'Time Up and Go' test for functional mobility, 'Prosthetic Satisfaction Index' for prosthetic satisfaction and 'Amputee Body Image Scale' for body. There were statistically significant difference between PS and AVS in terms of prosthetic side weight bearing percentage, walking capacity, functional mobility and prosthetic satisfaction (p\<0.05), in favor of AVS. There were not statistically significant difference between the body image scores (p\>0.05). From the view of function and prosthetic satisfaction, AVS was found to be more effective in transtibial amputees. It is believed that our study will be a guide to the future studies including higher number of amputees, different amputation levels and different suspension systems.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.