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NCT00167570 · ClinicalTrials.gov registry record
Long Term Clinical Evaluation of SLS Transtibial Sockets
A clinical trial, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- 11
- Enrollment target
NCT00167570: Completed study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT00167570 is a clinical trial that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00167570 has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DEVICE Prosthetic socket fabricated using selective laser sintering
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2003-04 |
| Est. Completion | 2011-07 |
What the finished NCT00167570 record still lists
NCT00167570 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Prosthetic socket fabricated using selective laser sintering is the first listed.
NCT00167570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00167570 about?
NCT00167570 is a clinical study titled "Long Term Clinical Evaluation of SLS Transtibial Sockets". 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...
What is the current status of trial NCT00167570?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2003-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00167570?
The interventions under investigation include: Prosthetic socket fabricated using selective laser sintering (DEVICE).
Who is sponsoring clinical trial NCT00167570?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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