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Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets
NCT03544853 · View on ClinicalTrials.gov ↗
Study Summary
The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The main hypothesis of this proposal is that the novel quantitative interface is equivalent to, or better than, a conventional interface in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire.
Conditions Studied
Interventions
- DEVICE Prosthetic socket for transtibial amputee
Study Locations (2)
Massachusetts
- Massachusetts Institute of Technology, Media Lab — Cambridge
Jalisco
- Tecnologico de Monterrey, Biomechatronics Lab — Nuevo México
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03544853
The ClinicalTrials.gov registry entry for NCT03544853 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Institute of Technology, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amputation Stump appearing as the primary indexed condition, and to 1 intervention — of which Prosthetic socket for transtibial amputee is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03544853 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Jalisco. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03544853 about?
NCT03544853 is a clinical study titled "Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets". The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The...
What is the current status of trial NCT03544853?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-09-15. Estimated completion is 2022-08-31.
What conditions does trial NCT03544853 study?
This clinical trial studies the following conditions: Amputation Stump. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03544853?
The interventions under investigation include: Prosthetic socket for transtibial amputee (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03544853?
This trial is sponsored by Massachusetts Institute of Technology, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03544853 being conducted?
This trial has 2 study locations across Massachusetts, Jalisco. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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