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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Socket Designs of Transfemoral Amputees.
Interventions Device: Standard of care socket
Device: Prosthetic brimless socket
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care Prosthetic Socket (Ischial Containment) Prosthetic Socket (Experimental): Brimless Socket
Hide Arm/Group Description In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition. 5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
Period Title: Control Condition: Ischial Containment
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Experimental Condition: Brimless
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Active Comparator: Prosthetic Socket Standard of Care Active Comparator: Prosthetic Brimless Socket Total
Hide Arm/Group Description This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity. This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity. Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  80.0%
5
 100.0%
9
  90.0%
>=65 years
1
  20.0%
0
   0.0%
1
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
42.9  (14.7) 42.9  (14.7) 42.9  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
1
  20.0%
1
  20.0%
2
  20.0%
Male
4
  80.0%
4
  80.0%
8
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Gait
Hide Description Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
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.
Outcome Measure Data Not Reported
2.Primary Outcome
Title Balance and Stability
Hide Description Balance and stability will be assessed for limits of stability and postural 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.
Outcome Measure Data Not Reported
3.Primary Outcome
Title Quality of Life
Hide Description Validated surveys will be used to solicit participants' subjective experience and feedback.
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.
Outcome Measure Data Not Reported
4.Primary Outcome
Title Socket Pressure
Hide Description Pressure sensors are placed on the skin and measured.
Time Frame 10 minutes after fitting with both sockets
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Condition: Prosthetic Socket Standard of Care Active Comparator/Experimental: Prosthetic Brimless Socket
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
841  (600) 819  (455)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vacuum Assisted Socket Standard of Care Socket
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Vacuum Assisted Socket Standard of Care Socket
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Vacuum Assisted Socket Standard of Care Socket
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vacuum Assisted Socket Standard of Care Socket
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason Highsmith
Organization: University of South Florida
Phone: 813-974-3806
EMail: mhighsmi@health.usf.edu
Layout table for additonal information
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01416129    
Other Study ID Numbers: 6140101600
First Submitted: August 11, 2011
First Posted: August 12, 2011
Results First Submitted: October 19, 2012
Results First Posted: June 2, 2014
Last Update Posted: June 2, 2014