A Novel Approach to Upper Extremity Amputation

This study is exploring a new way to perform upper arm or forearm amputations. The goal is to improve how people control advanced prosthetic limbs and to help them regain a sense of feeling and position (proprioception) in the amputated limb. Researchers will compare a modified amputation procedure, which involves carefully arranging muscle pairs, to the standard amputation procedure. They will measure how well participants can control their prosthetic, how much movement they have, and how much feeling they recover over 0-36 months. This study is for individuals aged 18-65 who are candidates for an upper extremity amputation due to injury, birth defects, or severe arthritis.

Study design
This interventional study plans to enroll 20 participants. Ten participants will receive the modified amputation procedure, and ten will receive the standard amputation procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 36 months after their procedure to assess motor control and proprioception recovery.

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NCT03882073

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

Recruiting
NAAges 18–65InterventionalTreatment
Brigham and Women's Hospital
~20 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Modified amputation procedureStandard amputation procedure

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Motor Unit Innervation
Measured over 0-36 months
+2 more outcomes measured
Amputation

NCT03882073

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham & Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Massachusetts Institute of Technology Media Lab

    Cambridge, Massachusettsstudy coordinator listed

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Matthew J Carty, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

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Eligibility criteria

Inclusion

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

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
  • Motor Unit Innervation0-36 months

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

  • Motor Unit Excursion0-36 months

    Intact volitional activation of motor constructs with measurable excursion, as assessed by ultrasound (excursion measured in mm)

  • Proprioception Recovery0-36 months

    Manifestation of functional proprioception with motor unit activation, as evidenced by spatial limb position testing using a modified upper limb prosthesis (accurate limb positioning relative to target measured in mm)