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Clinical Evaluation of Direct Manufactured Prosthetic Sockets

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ClinicalTrials.gov Identifier: NCT01155024
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ohio Willow Wood

Tracking Information
First Submitted Date  ICMJE June 29, 2010
First Posted Date  ICMJE July 1, 2010
Results First Submitted Date  ICMJE October 26, 2011
Results First Posted Date  ICMJE January 11, 2012
Last Update Posted Date January 11, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting [ Time Frame: Within the first 4-6 hrs ]
The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
Socket Comfort Score [ Time Frame: Within the first 4-6 hrs ]
Prosthetist and patient socket comfort/fit assessment using evaluation forms;
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
  • Participant Socket Preference After Initial Fitting [ Time Frame: Within the first 4-6 hours ]
    Number of participants indicating socket preference after initial fitting of both socket interventions
  • Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket [ Time Frame: 3 months ]
    Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • Socket Pressure Measurements [ Time Frame: Within the first 4-6 hours ]
  • Clarity Assessment [ Time Frame: Within the first 4-6 hours ]
  • Socket Comfort Score [ Time Frame: 3-6 Months ]
    Prosthetist and patient socket comfort/fit assessment using evaluation forms
  • Socket Selection [ Time Frame: Within the first 4-6 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Official Title  ICMJE Clinical Evaluation of Direct Manufactured Prosthetic Sockets
Brief Summary The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
Detailed Description

Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees increase at a high rate, the limited number of certified prosthetists is finding it harder to satisfy the patient demand. Therefore, the overall goal is to provide the Orthopedic & Prosthetic (O&P) industry with a tool that accommodates the increasing prosthetist to patient ratio and still provide acceptable product quality.

The practice of creating prosthetic sockets by the plaster-casting of amputees' residual limbs has been around for decades but continues to be the most commonly used method for the shape capture, modification and fabrication of prosthetic sockets. Using this traditional plaster-casting approach has many limitations that can now be overcome through the use of technology.

With the advancing developments in Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technologies over the past ten years, it is now possible to completely replace the plaster-casting approach with handheld, portable scanners.

While this current CAD/CAM approach certainly creates substantial efficiencies in the clinical aspects of creating the prosthetic socket, the actual manufacturing of the prosthetic device continues to rely on the use of a positive model and a lengthy manual fabrication process.

The continuing development of direct manufacturing technologies may serve as the final piece in the effective utilization of CAD/CAM in the care of prosthetic and orthotic patients. Direct manufacturing provides a means to quantify alterations and accurately reproduce prosthetic sockets. Additionally, direct manufacturing has the potential to reduce time, cost, and waste, as a result improve the quality and care ability to patients.

This study will compare two fabrication techniques for diagnostic and definitive sockets: manually fabricated (positive model technique) and direct manufactured (experimental).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Amputation
Intervention  ICMJE
  • Device: Traditional fabricated prosthetic socket
    A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.
    Other Name: Rectified prosthetic socket
  • Device: Direct manufactured (DM) prosthetic socket
    A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)
Study Arms  ICMJE
  • Traditional Socket First, then DM Socket
    Initial fitting of a traditional diagnostic prosthetic socket in first intervention period and initial fitting of a direct manufactured prosthetic socket in the second intervention period
    Interventions:
    • Device: Traditional fabricated prosthetic socket
    • Device: Direct manufactured (DM) prosthetic socket
  • DM Socket First, then Traditional Socket
    Initial fitting of a direct manufactured prosthetic socket in first intervention period and initial fitting of a traditional diagnostic prosthetic socket in the second intervention period
    Interventions:
    • Device: Traditional fabricated prosthetic socket
    • Device: Direct manufactured (DM) prosthetic 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: June 29, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be a lower extremity amputee longer than one year
  • Be a consenting adult (at least 18 years or age or older)
  • Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
  • Currently using a liner with prosthesis
  • Be available during regular business hours for appointments

Exclusion Criteria:

  • An inability to give informed consent
  • Presence of any sores, lacerations or rashes on the residual limb
  • Impaired contra lateral foot
  • Poor distal sensation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01155024
Other Study ID Numbers  ICMJE W81XWH-08-10700-V1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ohio Willow Wood
Study Sponsor  ICMJE Ohio Willow Wood
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: James Colvin, M.S. Ohio Willow Wood
PRS Account Ohio Willow Wood
Verification Date December 2011

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