What is this study trying to find out about amputation?

This study is evaluating a new surgical technique to improve motor control, restore sensation, and reverse muscle loss in patients with lower limb amputations. Researchers aim to see if the biological implants can reduce phantom limb pain and improve prosthetic use. The study is led by Brigham and Women's Hospital.

Who may be eligible for this amputation clinical trial?

Adults between 18 and 65 years old who have already had an above or below knee amputation may be eligible. Participants should have symptoms like pain or skin issues around their residual limb and be healthy enough for surgery. They also need good communication skills and motivation. 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. However, personal expenses like travel may vary and are not guaranteed to be reimbursed.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID04063592

Surgical Revision of Lower Limb Amputations to Improve Muscle Control, Sensation, and Reverse Muscle Loss

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 studying a new surgical method for patients with lower extremity amputations. This approach aims to improve motor control, restore proprioception, reduce phantom limb pain, and reverse muscle loss in residual limbs. The study focuses on revising above knee and below knee amputations using innovative biological actuators. Participants will undergo a surgical procedure called residual limb revision, which constructs agonist-antagonist myoneural interfaces AMIs in their residual limbs. These biological actuators are designed to enhance muscle and nerve function, with the goal of improving movement control and sensory feedback. The study will also develop a specialized rehabilitation strategy tailored to this surgery. Throughout the study, participants will be monitored for changes in muscle volume, motor activation, sensory perception, proprioception, general health, and any complications. These measures will be collected over a period of one to three years post-surgery to evaluate the effectiveness and durability of the surgical revision and rehabilitation techniques.

CONDITIONS

Brief Title

AMI Construction in Lower Extremity Residual Limbs

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Between the ages of 18-65
Has already undergone a standard above knee (AKA) or below knee amputation (BKA)
Experiences symptoms such as intractable pain, skin deterioration near the stump, or other discomfort from the residual limb
Has intact wound healing ability
Possesses adequate communication skills
Demonstrates high motivation

You will not qualify if you...

Not healthy enough for surgery with standard anesthesia (e.g., cardiopulmonary issues)
Has impaired wound healing
Suffers from extensive peripheral neuropathies
Active smoker
History of poor compliance
Pregnant or plans to become pregnant before surgery

Research Team

Matthew J Carty, MD

Research Coordinators

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