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NCT03374319 · ClinicalTrials.gov registry record · NA

Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
50
Enrollment target

NCT03374319: Completed NA study, sponsored by Brigham and Women's Hospital.

NCT03374319 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03374319, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target

Study Summary

The hypothesis of this research protocol is that we will be able to redesign the manner in which lower limb amputations are performed so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses. The specific aims of the project are as follows: 1. To define a standardized approach to the performance of a novel operative procedure for both below knee (BKA) and above knee (AKA) amputations 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive and other sensory feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BKA and AKA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Primary Outcome

Intact volitional activation of motor constructs, as assessed by electromyographic evidence of activation (muscle potentials measured in mV)

Interventions

  • PROCEDURE Modified amputation procedure

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2017-09-15
Est. Completion 2024-09-30
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT03374319 record still lists

NCT03374319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Modified amputation procedure is the first listed.

NCT03374319 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03374319 about?

NCT03374319 is a clinical study titled "Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations". The hypothesis of this research protocol is that we will be able to redesign the manner in which lower limb amputations are performed so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses. The specific aims of the project are a...

What is the current status of trial NCT03374319?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2017-09-15. Estimated completion is 2024-09-30.

What interventions are being tested in trial NCT03374319?

The interventions under investigation include: Modified amputation procedure (PROCEDURE).

Who is sponsoring clinical trial NCT03374319?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03374319's enrollment target sits among peer trials

50 1279th of 2000 higher than 622 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03374319, the US trial registry maintained by the National Library of Medicine. NCT03374319 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.