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Southern Bone & Joint Study - Brimless Sockets

This study has been completed.
Sponsor:
Collaborator:
Southern Bone & Joint Specialists, P.A.
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01416129
First received: August 11, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Socket Designs of Transfemoral Amputees.
 Device: Standard of care socket
Device: Prosthetic brimless socket
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces

Resource links provided by NLM:

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Gait [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Gait will be assessed in terms of biomechanics and spatiotemporal parameters.

  • Balance and stability [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Balance and stability will be assessed for limits of stability and postural stability.

  • Quality of Life [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Validated surveys will be used to solicit participants' subjective experience and feedback.

  • Socket pressure [ Time Frame: 10 minutes after fitting with both sockets ] [ Designated as safety issue: No ]
    Pressure sensors are placed on the skin and measured.


Enrollment: 10
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416129

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Southern Bone & Joint Specialists, P.A.
Investigators
Principal Investigator: Jason Highsmith, PT,DPT,CP University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01416129     History of Changes
Other Study ID Numbers: 6140101600
Study First Received: August 11, 2011
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013