New surgery could give amputees 'Bionic' control over prosthetic legs
NCT ID NCT03374319
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to perform leg amputations that connects muscles in the residual limb to act as biological motors. The goal is to allow people to control advanced prosthetic legs more naturally and with better feeling. Fifty adults needing a leg amputation due to injury, birth defects, or arthritis took part. The approach aims to improve how well the remaining muscles can be activated and sensed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Modified amputation procedure (agonist-antagonist myoneural interface)
- What this could lead to
- If successful, this could lead to a standard surgical technique that gives people with leg amputations better control and feeling in their prosthetic limbs.
- What could go wrong
- This is a small, early-stage study with only 50 participants, so results may not apply to everyone. There are also risks like infection, poor wound healing, or the need for additional surgeries.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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Sep 2017
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males or females between the ages of 18 and 65 * Candidates for elective unilateral or bilateral lower extremity amputation at either the above knee or below knee level due to traumatic injury, congenital limb deformities or progressive arthritis * Must demonstrate sufficiently sound health to undergo the operative procedure, including adequate cardiopulmonary stability to undergo general anesthesia (specifically, American Society of Anesthesiology Class I or II) * Must have intact inherent wound healing capacity * Must demonstrate adequate communication skills to convey the status of their sensorimotor recovery throughout the postoperative phase, * Must exhibit proper level of motivation to comply with postoperative follow up requirements. Exclusion Criteria: * Patients beyond the stated age restrictions * Those with severe illness rendering them unable to undergo the operative procedure safely (e.g., unresolved sepsis or cardiopulmonary instability manifest as documented coronary artery disease and/or chronic obstructive pulmonary disease). * Patients with impairment in inherent wound healing pathways, such as those with primary connective tissue disorders or those on chronic steroid therapy * Patients with extensive peripheral neuropathies (diabetic or otherwise) that would potentially inhibit appropriate reinnervation of the surgical constructs * Active smokers; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively * Patients who are unable to provide informed consent and those with a demonstrated history of poor compliance * Pregnant women will not be considered due to the potential risks of general anesthesia. Patients will not be excluded from participation in the study on the grounds of minority status, religious status, race or gender. Non-English speaking patients will not be excluded from the study; interpreters will be made available to them for translation of both verbal interactions and written documents.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, 02114, United States
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Massachusetts Institute of Technology Media Lab
Cambridge, Massachusetts, 02139, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can we predict prosthetic success? a study seeks answers
- Can bionic limbs feel real? a trial tests touch feedback for amputees
- Can a common anesthetic dampen phantom limb pain?
- Can tiny electrodes give amputees a better grip on bionic limbs?
- FitBit coaching may help amputees walk more after surgery