Long Term Clinical Evaluation of SLS Transtibial Sockets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00167570
First received: September 9, 2005
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

The overall long-term goal of this project is the development of a clinically practical system for rapid prosthetic limb provision that integrates computer-aided design with solid freeform fabrication techniques. This proposal builds on our previous successful demonstration of the feasibility of SFF socket fabrication and will address several key issues that underlie its clinical viability. The specific objectives of the proposed work are:

  1. To develop improved designs for SFF transtibial prosthetic sockets that allow the use of industry standard pylon mounts and incorporate variable compliance elements.
  2. Determine the clinical effectiveness of variable wall compliance elements in enhancing the comfort and fit of transtibial prosthetic sockets.
  3. Determine the durability and functionality of SFF sockets during extended clinical use.

These objectives will be met over a three-year period. The initial phase of the proposed work will use an iterative engineering design - modeling - evaluation process to develop variable compliance elements and an industry standard pylon mount adapter. During the second phase of the proposed work, clinical evaluations of SFF prosthetic sockets will be studied. The effectiveness of variable compliant elements in enhancing comfort and fit will be determined using a within subject case comparison study of SFF sockets with conventional laminated sockets. Durability of SFF sockets that incorporate an industry standard pylon mounting system will be determined during a 12-month clinical field trial.


Condition Intervention
Trauma
Diabetes
Device: Prosthetic socket fabricated using selective laser sintering

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Long Term Clinical Evaluation of SLS Transtibial Sockets

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Durability during household and community mobility. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Subjects were followed for up to 12 months in 3 months intervals for examination of the physical condition of socket and for subject gait assessment with socket


Secondary Outcome Measures:
  • User perceptions of comfort, fit, and function. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Subjects were followed up at 3 month intervals and assessed for comfort fit and function


Enrollment: 11
Study Start Date: April 2003
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Prosthetic socket improvement design
Changes made to prosthetic for assessment of comfort and fit improvement.
Device: Prosthetic socket fabricated using selective laser sintering

Detailed Description:

Successful rehabilitation for the majority of lower extremity amputees includes prosthetic limb fitting and training. Critical to the success of prosthetic fitting is a comfortable, well fitting socket. Accomplishing this remains a clinical challenge with residual limb pain and socket discomfort affecting 20-55% of lower limb amputees. Achieving an acceptable socket fit using conventional prosthetic techniques requires individual custom molding and fabrication in a labor intensive, costly process. Alternative methods of fabricating prosthetic sockets that can improve efficiency in prosthetic provision, enhance comfort and fit, or reduce cost are needed to ensure the continued optimal rehabilitation of the amputee. This project will continue the development of a new promising method of socket fabrication using solid freeform fabrication (SFF) based on selective laser sintering (SLS) technology. SFF allows the direct manufacture of a prosthetic socket without the intermediate molds and laminating process required with conventional techniques.

The overall long-term goal of this project is the development of a clinically practical system for rapid prosthetic limb provision that integrates computer-aided design with solid freeform fabrication techniques. This proposal builds on our previous successful demonstration of the feasibility of SFF socket fabrication and will address several key issues that underlie its clinical viability. The specific objectives of the proposed work are:

  1. To develop improved designs for SFF transtibial prosthetic sockets that allow the use of industry standard pylon mounts and incorporate variable compliance elements.
  2. Determine the clinical effectiveness of variable wall compliance elements in enhancing the comfort and fit of transtibial prosthetic sockets.
  3. Determine the durability and functionality of SFF sockets during extended clinical use.

These objectives will be met over a three-year period. The initial phase of the proposed work will use an iterative engineering design - modeling - evaluation process to develop variable compliance elements and an industry standard pylon mount adapter. During the second phase of the proposed work, clinical evaluations of SFF prosthetic sockets will be studied. The effectiveness of variable compliant elements in enhancing comfort and fit will be determined using a within subject case comparison study of SFF sockets with conventional laminated sockets. Durability of SFF sockets that incorporate an industry standard pylon mounting system will be determined during a 12-month clinical field trial.

  Eligibility

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

Inclusion Criteria:

All subjects will be lower extremity amputees of at least one year duration and are 18 years of age or older.

They must meet the Medicare Functional Classification Level K2 or K3 class for prosthetic use (unlimited household or limited community level ambulator).

Exclusion Criteria:

There must be no current stump wounds or breakdown or a history of repeated skin breakdown with adequately fitting prostheses.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167570

Locations
United States, Texas
South Texas Veterans Healthcare System
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Nicolas Walsh, MD University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00167570     History of Changes
Other Study ID Numbers: VA-A2755-r-UT-001-0011-267, VA-A2755-r
Study First Received: September 9, 2005
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Artificial Limbs
Amputees
Computer-Aided Design

ClinicalTrials.gov processed this record on April 16, 2014