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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

Tracking Information
First Submitted Date  ICMJE August 11, 2011
First Posted Date  ICMJE August 12, 2011
Results First Submitted Date  ICMJE October 19, 2012
Results First Posted Date  ICMJE June 2, 2014
Last Update Posted Date June 2, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • 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.
  • 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.
  • 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.
  • Socket Pressure [ Time Frame: 10 minutes after fitting with both sockets ]
    Pressure sensors are placed on the skin and measured.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
  • 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.
  • 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.
  • 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.
  • Socket pressure [ Time Frame: 10 minutes after fitting with both sockets ]
    Pressure sensors are placed on the skin and measured.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Southern Bone & Joint Study - Brimless Sockets
Official Title  ICMJE Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Socket Designs of Transfemoral Amputees.
Intervention  ICMJE
  • Device: Standard of care socket
    Amputees' preferred socket.
  • Device: Prosthetic brimless socket
    Study socket
Study Arms  ICMJE
  • Active Comparator: Active Comparator: Prosthetic socket standard of care
    Intervention: Device: Standard of care socket
  • Active Comparator: Active Comparator: Prosthetic brimless socket
    Intervention: Device: Prosthetic brimless socket
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2011)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01416129
Other Study ID Numbers  ICMJE 6140101600
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE Southern Bone & Joint Specialists, P.A.
Investigators  ICMJE
Principal Investigator: Jason Highsmith, PT,DPT,CP University of South Florida
PRS Account University of South Florida
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP