Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees

Amputation Clinical Trial

Official title:

Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559909
• Other study ID #: 197622
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2011
• Last updated: May 8, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female between the ages of 21 and 75 with a transfemoral amputation.

• Limited household ambulators (K1) to those considered unlimited community ambulators (K4).

• People who are comfortably fitted with a prosthesis for at least 6 months.

Exclusion Criteria:

• People with severe cardiac or pulmonary disease that limits ability to walk.

• People with too much discomfort and/or pain.

• People with active wounds on their residual limb or other foot.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
The brim height of the socket will be systematically reduced

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York
United States	Long Island Orthotics and Prosthetics	West Babylon	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Otto Bock Healthcare Products GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait changes	Step length, stride length, stance time, swing time, velocity	1 day	No
Secondary	Comfort		1 day	No
Secondary	Balance		1 day	No