Southern Bone & Joint Study - Brimless Sockets

Phase 3

Completed

• Conditions: Socket Designs of Transfemoral Amputees.
• Interventions: Device: Standard of care socket; Device: Prosthetic brimless socket

• Registration Number: NCT01416129
• Lead Sponsor: University of South Florida

Brief Summary

The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-07
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Completion: 2011-10
• Results First Submitted: 2012-10-19
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-06
• Last Update Submitted: 2014-05-06
• Results First Posted: 2014-06-02
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Unilateral transfemoral or knee-disarticulation amputee
• 18 to 85 years of age
• K3 (variable cadence and community) ambulators;
• Be able to independently provide informed consent
• Be willing to comply with study procedures.

Exclusion Criteria

• History of chronic skin breakdown on the residual limb
• Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
• Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
• Unwillingness/inability to follow instructions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Comparator: Prosthetic socket standard of care	Standard of care socket	-
Active Comparator: Prosthetic brimless socket	Prosthetic brimless socket	-

Primary Outcome Measures

Name	Time	Method
Balance and Stability	Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.	Balance and stability will be assessed for limits of stability and postural stability.
Quality of Life	Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.	Validated surveys will be used to solicit participants' subjective experience and feedback.
Gait	Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.	Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
Socket Pressure	10 minutes after fitting with both sockets	Pressure sensors are placed on the skin and measured.

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States