Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID03882073

A Novel Surgical Approach to Upper Limb Amputation to Enhance Prosthetic Control and Restore Sensation

Led by Brigham and Women's Hospital · Updated on 2025-10-20

20

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

M

Massachusetts Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new surgical approach to upper limb amputation aimed at improving control and sensation for advanced prosthetic devices. The study compares a modified amputation technique designed to preserve muscle dynamics and restore proprioception with standard amputation methods. This phase I pilot trial involves ten patients receiving the new procedure and ten controls with traditional amputations, conducted over three years at multiple medical centers. The modified procedure involves creating dynamic agonist-antagonist muscle pairings in the residual limb to enable better motor control and sensory feedback. Surgeons will isolate and reconnect specific muscles and nerves to promote natural muscle interactions, while standard amputations follow traditional methods without these reconstructions. Sensory nerve endings are redirected to skin patches to enhance feedback, and the surgical site is carefully closed with drainage. Outcomes will be assessed up to 36 months post-operation. Participants will undergo detailed evaluations including motor unit innervation, movement range, and proprioception recovery. Researchers will monitor safety through infection rates, wound healing, and other complications. Functional and sensory outcomes will also be assessed alongside general health and muscle condition. Follow-up includes rehabilitation tailored to the new technique, with assessments conducted at involved hospitals and Massachusetts Institute of Technology. Total participation spans three years from surgery.

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

Eligible

You may qualify if you...

  • Male or female between 18 and 65 years old
  • Candidate for elective unilateral or bilateral upper limb amputation above or below the elbow due to trauma, congenital deformity, or arthritis
  • Adequate health to safely undergo general anesthesia (ASA Class I or II)
  • Intact wound healing ability
  • Able to communicate sensorimotor recovery status during follow-up
  • Motivated to comply with postoperative follow-up
  • Willing to consent to study activities including assessments at MIT
Not Eligible

You will not qualify if you...

  • Outside the age range of 18 to 65 years
  • Severe illness making surgery unsafe (e.g., unresolved sepsis, significant heart or lung disease)
  • Active infection in the arm to be amputated
  • Taking immunosuppressive medications
  • Impaired wound healing due to connective tissue disorders or chronic steroid use
  • Extensive peripheral neuropathy that may hinder nerve regeneration
  • Active smokers (must abstain from tobacco for at least 6 weeks prior if willing to quit)
  • Unable to provide informed consent or history of poor compliance
  • Pregnant women due to anesthesia risks
  • Minority status, race, religion, gender, or language differences do not exclude participation; interpreters available if needed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo either a modified or standard upper limb amputation procedure to prepare the residual limb for prosthetic control and proprioception restoration.

1 surgical visit (in-person)

Follow-up

Duration - Up to 36 months

Participants are monitored for recovery of motor control, proprioception, sensory function, and potential complications following amputation.

Regular follow-up visits during recovery period

Trial Site Locations

Total: 4 locations

1

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Actively Recruiting

2

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Massachusetts Institute of Technology Media Lab

Cambridge, Massachusetts, United States, 02139

Actively Recruiting

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Research Team

M

Matthew J Carty, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A critical review of interfaces with the peripheral nervous system for the control of neuroprostheses and hybrid bionic systems.

Xavier Navarro, Thilo B Krueger, Natalia Lago...

https://pubmed.ncbi.nlm.nih.gov/16221284

A murine model of a novel surgical architecture for proprioceptive muscle feedback and its potential application to control of advanced limb prostheses.

Tyler R Clites, Matthew J Carty, Shriya Srinivasan...

https://pubmed.ncbi.nlm.nih.gov/28211795