Revolutionary amputation technique could give amputees bionic control
NCT ID NCT03882073
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study tests a new way to perform arm amputations that may allow people to better control advanced prosthetic arms and even feel where their limb is in space. Twenty participants will be split into two groups: ten will get the new surgery, and ten will have a standard amputation. The goal is to see if the new approach improves movement, sensation, and quality of life.
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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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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- 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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Accepted
You do not need to have the condition being studied to take part.
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 upper extremity amputation at either the above elbow or below elbow 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 * Must be willing to also consent to study activities taking place at Massachusetts Institute of Technology (approved under same IRB protocol via ceded IRB review) as some outcome measures will be assessed at that site 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 active infections, particularly deep infections in the arm to be amputated * Patients who are taking immunosuppressive agents * 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham & Women's Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Massachusetts Institute of Technology Media Lab
RECRUITINGCambridge, Massachusetts, 02139, United States
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Walter Reed National Military Medical Center
RECRUITINGBethesda, Maryland, 20889, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a motorized knee help amputees walk more? trial puts it to the test
- 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