Innovative surgery for improving lower limb prosthetics and reducing pain in amputees
Official title: A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy
Run by Brigham and Women's Hospital · NCT04063592 · Data updated 2026-11-12
This study is testing a new type of surgery for amputees to see if it can help reduce pain and improve movement by using special devices in their residual limb.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 3 sites (Bethesda, Maryland and 2 other locations) |
| Status | Recruiting |
| Started | February 24, 2020 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT04063592 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-65 who have undergone above or below knee amputation and experience significant pain or discomfort from their residual limb.
✕Probably not a fit
Patients who are not in good health to undergo surgery, have impaired wound healing, or suffer from extensive peripheral neuropathies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on a novel surgical revision technique for patients with lower extremity amputations, aiming to enhance motor control and sensory feedback through the incorporation of biological actuators in the residual limb. The research will evaluate the effectiveness of this approach in alleviating phantom limb pain, restoring proprioception, and regenerating muscle mass. Specific aims include developing a standardized surgical technique, assessing the functionality of the actuators, and creating a tailored rehabilitation strategy for post-operative care.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for amputees by reducing pain and enhancing the functionality of prosthetic limbs.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in enhancing prosthetic control and reducing phantom pain, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between the ages of 18-65 * Has already undergone a standard AKA or BKA procedure * Suffers from symptoms such as: * Intractable pain * Deterioration of skin on or around stump * Suffering from other sources of discomfort arising from stump * Intact inherent wound healing * Adequate communication skills * High motivation Exclusion Criteria: * Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary) * Individuals with impaired wound healing * Individuals suffering from extensive peripheral neuropathies * Active smokers * Individuals with a history of poor compliance * Women who are pregnant or plan to become pregnant before surgical intervention
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States Recruiting -
Walter Reed National Military Medical Center
Bethesda, Maryland, United States Not yet recruiting
Study contacts
- Principal investigator: Matthew J Carty, MD — Brigham and Women's Hospital
- Study coordinator: Matthew J Carty, MD
- Email: mcarty@partners.org
- Phone: 6179834555
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing powered and mechanical prosthetic knees for K2-level amputees
This study is testing whether powered prosthetic knees work better than mechanical ones for K2-level amputees to help improve their mobility and make better choices for future prosthetic designs.
-
Effect of EMG sensor number and placement on control of below-elbow prosthetic arms
This project will test whether changing the number and placement of myoelectric sensors helps adults with below-elbow limb absence control a prosthetic arm better while wearing a real device.
-
Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee amputation.
This test will see if switching to a microprocessor-controlled prosthetic knee reduces fall-related health problems and improves walking speed, mobility, and quality of life for adults with above-knee amputations who are limited community ambulators compared with non-microprocessor knees.
-
Understanding the impact of powered prosthetics on walking for transfemoral amputees
This study is testing whether powered knee and ankle prosthetics can help transfemoral amputees walk better, especially when combined with special training.
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Evaluation of a new myoelectric prosthesis for transradial amputees
This study is testing a new type of prosthetic arm that uses a special implant to help people with below-the-elbow amputations control it more easily and naturally.
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Hand prosthesis usability and performance evaluation for people with upper limb absence
This study tests a new multi-articulating hand prosthesis to see if it performs better or differently than a participant’s own prosthesis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.