Long Term Clinical Evaluation of SLS Transtibial Sockets
Completed
Conditions studied: Trauma, Diabetes
In brief
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.
Key facts
- Study ID
- NCT00167570
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 11
- Starts
- 2003-04-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2017-04-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- There must be no current stump wounds or breakdown or a history of repeated skin breakdown with adequately fitting prostheses.
Where it is running
- South Texas Veterans Healthcare System — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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