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Southern Bone & Joint Study - Brimless Sockets

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ClinicalTrials.gov Identifier: NCT01416129
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
Southern Bone & Joint Specialists, P.A.
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. 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. ]
    Gait will be assessed in terms of biomechanics and spatiotemporal parameters.

  2. 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. ]
    Balance and stability will be assessed for limits of stability and postural stability.

  3. 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. ]
    Validated surveys will be used to solicit participants' subjective experience and feedback.

  4. Socket Pressure [ Time Frame: 10 minutes after fitting with both sockets ]
    Pressure sensors are placed on the skin and measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01416129     History of Changes
Other Study ID Numbers: 6140101600
First Posted: August 12, 2011    Key Record Dates
Results First Posted: June 2, 2014
Last Update Posted: June 2, 2014
Last Verified: May 2014