What is this study trying to find out about amputation?

This study is evaluating a new surgical method for upper limb amputation to improve control and restore sensation in the amputated limb. Researchers aim to see if the modified procedure offers better motor function and proprioceptive feedback compared to standard amputation. The trial is sponsored by Brigham and Women's Hospital and involves testing advanced biological interfaces for prosthetic control.

Who may be eligible for this amputation clinical trial?

Adults aged 18 to 65 who require elective upper limb amputation above or below the elbow may be eligible. Participants must be healthy enough for surgery, able to communicate recovery status, and willing to follow up after surgery. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this amputation clinical trial?

Study-related care, including the surgery and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study appointments.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID03882073

A New Surgical Method for Upper Limb Amputation to Improve Control and Sensation with Advanced Prosthetics

Led by Brigham and Women's Hospital · Updated on 2026-07-09

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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

Brief Title

A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

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

Research Team

Matthew J Carty, MD

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