Southern Bone & Joint Study - Brimless Sockets

Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces

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.

Study Overview

• Status: Completed
• Conditions: Socket Designs of Transfemoral Amputees.
• Intervention / Treatment: Device: Standard of care socket; Device: Prosthetic brimless socket

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator: Prosthetic socket standard of care	Device: Standard of care socket; Amputees' preferred socket.
ACTIVE_COMPARATOR: Active Comparator: Prosthetic brimless socket	Device: Prosthetic brimless socket; Study socket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait	Gait will be assessed in terms of biomechanics and spatiotemporal parameters.	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	Balance and stability will be assessed for limits of stability and postural 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.
Quality of Life	Validated surveys will be used to solicit participants' subjective experience and feedback.	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.
Socket Pressure	Pressure sensors are placed on the skin and measured.	10 minutes after fitting with both sockets

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Southern Bone & Joint Specialists, P.A.
• Investigators: Principal Investigator: Jason Highsmith, PT,DPT,CP, University of South Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (ESTIMATE): August 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 6140101600