Limb Revision Surgery for Amputation

Recruiting at 2 trial locations

Overseen By Research Coordinators

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cardiopulmonary issues, Peripheral neuropathies, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve surgical methods for individuals who have undergone leg amputations. The goal is to assist those experiencing intense pain, skin issues, or other discomfort with their residual limb. The study will explore a new surgical technique called residual limb revision, which could enhance muscle control and reduce muscle wasting. Participants are needed who have had a previous above-knee or below-knee amputation and are currently dealing with issues like persistent pain or skin problems around the amputation site. As an unphased trial, this study offers participants the chance to contribute to innovative surgical advancements that could significantly enhance the quality of life for amputees.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical revision technique is safe?

Research has shown that most patients handle residual limb revision surgery well. One study found that 81% of patients had successful surgeries, experiencing good results. The same study reported that 63% of patients successfully adjusted during rehabilitation after surgery.

Another study identified infections and painful nerve growths (neuromas) as common reasons for needing revision surgery, indicating that while complications can occur, they are often manageable.

Overall, these findings suggest that residual limb revision surgery is relatively safe. Most patients do well with the procedure, although some may face issues like infections, which are usually treatable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Residual limb revision surgery is unique because it focuses on refining the remaining part of an amputated limb to improve comfort and prosthetic function. Unlike traditional treatments that often concentrate on managing pain or fitting prosthetics to unaltered stumps, this approach specifically aims to reshape the limb for better prosthetic compatibility and reduced discomfort. Researchers are excited because this technique could potentially lead to more personalized and effective prosthetic use, enhancing mobility and quality of life for amputees.

What evidence suggests that this surgical revision is effective for improving motor control and proprioception in limb amputation?

Research has shown that surgery to revise a residual limb can be very effective. In this trial, participants will undergo the proposed operative intervention. One study found that 81% of these surgeries were successful, indicating that most went well. Rehabilitation success reached 63%, showing that many patients improved their movement and function. Additionally, 89% of patients did not require another surgery on the limb within a year. These results suggest that the surgery helps maintain the limb's health and functionality over time. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew J Carty, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have had a below-knee (BKA) or above-knee (AKA) amputation and are experiencing intractable pain, discomfort from the stump, or skin deterioration around it. Participants should be highly motivated, able to communicate effectively, and possess natural wound healing abilities.

Inclusion Criteria

I experience discomfort from my amputation stump.

You are able to communicate effectively.

I experience severe, unmanageable pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Subjects undergo the proposed operative intervention to modify residual limbs and include biological actuators

1 week

1 visit (in-person)

Postoperative Rehabilitation

Development of a modified acute postoperative rehabilitation strategy suited to the new surgical approach

4-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and various outcome measures including general health, limb morphology, motor activation, proprioception, and sensory perception

Years 1-3

What Are the Treatments Tested in This Trial?

Interventions

• Residual limb revision

Trial Overview

The study is testing a new surgical technique for revising lower extremity residual limbs. The goal is to improve voluntary muscle control, restore sensation of limb position and movement (proprioception), and reverse muscle wasting (atrophy).

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39453607/

What Are the Factors Associated With Revision Surgery on ...

Results: A total of 85 patients (94 limbs) were included, of whom 25 (27 limbs) underwent a revision surgery on the residual limb > 6 months ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0020138321001145

Amputation Revision Surgery – Refining the surgical ...

Results: There was an overall surgical success rate of 81% and an overall rehabilitation success rate of 63%, with variable outcomes related to the indication ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9389065/

Postamputation Residual Limb Pain Severity and Prevalence

Mean residual limb pain severity at the 6 months or longer follow-up was 4.19 out of 10 for cancer amputations, 2.70 for traumatic amputations, 0.47 for ...

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa012604

An Analysis of Outcomes of Reconstruction or Amputation ...

At 24 months, 53.0 percent of the patients who underwent amputation and 49.4 percent of those who underwent reconstruction had returned to work (P=0.48). Table ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1877056825002385

Review article Post-traumatic lower-limb amputation

Revision-free survival for the residual limb is 89% at 1 year but only 65% at 5 years [19]. In military settings, more than half of stumps ...

6.

gulhanemedj.org

gulhanemedj.org/articles/stump-complications-leading-to-stump-revision-surgery-and-related-factors-in-individuals-with-trauma-related-lower-limb-amputation-a-7-year-retrospective-cohort-study/gulhane.galenos.2025.76258

Stump complications leading to stump revision surgery and ...

This study demonstrated that stump infection was the leading cause of revision surgery in trauma-related lower limb amputations, followed by neuroma.

7.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-025-06231-y

a two-year follow-up study from a level I trauma center

In our study, patients who underwent multiple limb amputations exhibited high rates of mortality (36.4%), complication-related reoperations ( ...