Human Implementation of Upper Extremity Amputation Incorporating Agonist-Antagonist Myoneural Interface Construction.
Matthew J Carty, Michael Fernandez, Corey L Sullivan...
https://pubmed.ncbi.nlm.nih.gov/41396271/Actively Recruiting
Led by Brigham and Women's Hospital · Updated on 2026-07-09
20
Participants Needed
4
Research Sites
N/A
Total Duration
Researchers are exploring a new surgical method for upper limb amputations to improve voluntary control and restore sensation and proprioception in amputated limbs. This phase I pilot trial will compare outcomes of modified above elbow or below elbow amputations with traditional amputations in adult patients. The study aims to develop a standardized procedure, measure motor control and proprioceptive feedback, and validate the benefits of the new technique over standard methods. Participants will receive either a modified amputation procedure that preserves or reconstructs dynamic muscle pairings and redirects sensory nerves, or a standard amputation without these modifications. The modified surgery targets specific muscles and nerves to create a biological interface that can better connect with next-generation prosthetic devices. Ten patients will receive the modified procedure and ten will undergo the standard approach, with some procedures performed at Brigham & Womens Hospital and others at Walter Reed National Military Medical Center. During the study, participants will be monitored for motor unit innervation, motor unit movement, and proprioceptive recovery over up to 36 months. Secondary outcomes include rates of infection, wound healing, surgical revisions, seroma formation, and mortality, as well as assessments of general health, muscle atrophy, and sensory recovery. Participants will provide feedback on their sensorimotor recovery and will be followed closely with various assessments to evaluate the functional and sensory outcomes of the new amputation technique.
CONDITIONS
A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
M
Matthew J Carty, MD
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Brigham and Women's Hospital
Lead Sponsor
Massachusetts Institute of Technology
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Modified amputation with agonist-antagonist myoneural interface | Standard amputation |
|---|---|---|
| What is it? | A surgical approach that reconstructs the residual limb by creating linked pairs of muscles and redirecting nerves to improve control, sensation, and potential integration with advanced prosthetics. | Conventional surgical technique that removes the limb without constructing specialized muscle pairs or redirecting nerves for enhanced feedback or control. |
| Role in trial | Investigational intervention being studied for its effects on motor control and sensory feedback. | Active comparator receiving the conventional surgical method. |
| Primary use or goal | To improve motor function, voluntary control, and sensation (proprioception) in people receiving upper limb amputation, supporting more intuitive prosthesis use. | Standard approach for surgical limb removal in candidates requiring amputation, typically allowing use of a conventional limb prosthesis. |
| How it is performed | During surgery, the residual limb is reconstructed using paired muscles; selected nerves are redirected to skin or muscle targets, and specialized connections are made to enhance feedback and engagement, followed by layered closure. | Conventional method where the limb is removed without creating muscle pairs or planned nerve redirection, focusing on residual limb closure. |
| Evidence status | Early clinical results suggest feasibility for implementing the procedure in humans, but its full effects on long-term function and sensation remain under clinical investigation. | Well-established technique with known surgical outcomes and prosthesis compatibility, but limited ability to restore natural sensation or voluntary motor feedback. |
| Important limitations or challenges | The novel procedure is more technically complex, may involve longer surgery and healing times, and has long-term functional outcomes that remain to be proven. Experience with the approach in routine care is limited. | While outcomes are reliable, conventional amputation does not typically allow for natural muscle-driven feedback or intuitive sensory experience with prostheses. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants undergo either a modified amputation procedure designed to preserve muscle function and sensation or a standard amputation procedure.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/19633463/Brigham and Women's Hospital
Lead Sponsor
Massachusetts Institute of Technology
Collaborating Sponsor