50 Participants Needed

Modified Amputation Procedure for Lower Limb Amputations

Recruiting at 3 trial locations
MJ
Overseen ByMatthew J Carty, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The hypothesis of this research protocol is that we will be able to redesign the manner in which lower limb amputations are performed so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses. The specific aims of the project are as follows: 1. To define a standardized approach to the performance of a novel operative procedure for both below knee (BKA) and above knee (AKA) amputations 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive and other sensory feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BKA and AKA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic steroid therapy, you may be excluded from the trial.

What data supports the effectiveness of the modified amputation procedure for lower limb amputations?

The research suggests that minor amputations, like the modified procedure, can lead to better functional outcomes and less energy consumption compared to major amputations. However, careful patient selection is crucial to ensure success and good functional outcomes.12345

Is the modified amputation procedure with TMR and RPNI safe for humans?

The modified amputation procedure using TMR (targeted muscle reinnervation) and RPNI (regenerative peripheral nerve interface) has been shown to reduce pain and improve outcomes in patients after amputation, suggesting it is generally safe for humans.678910

How is the modified amputation procedure with TMR and/or RPNI construction different from other treatments for lower limb amputations?

The modified amputation procedure with TMR (Targeted Muscle Reinnervation) and/or RPNI (Regenerative Peripheral Nerve Interface) construction is unique because it focuses on improving nerve function and reducing pain by rerouting nerves to new muscle targets, which can enhance prosthetic control and reduce phantom limb pain, unlike traditional amputation methods that do not address these issues.211121314

Research Team

MJ

Matthew J Carty, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for men and women aged 18-65 who need an elective lower limb amputation due to injury, deformity, or arthritis. They must be able to communicate well, be in good health for surgery under general anesthesia, have a natural ability to heal wounds, and be motivated to follow post-op instructions.

Inclusion Criteria

I am healthy enough for surgery and general anesthesia.
I am a candidate for leg amputation due to injury, birth defects, or severe arthritis.
My body can heal wounds normally.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo a modified amputation procedure incorporating innervated muscle segments for enhanced prosthetic control

1 week
1 visit (in-person)

Acute Postoperative Rehabilitation

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

4-8 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for motor unit excursion, proprioception recovery, and other postoperative outcomes

48 months
Regular follow-up visits (in-person)

Treatment Details

Interventions

  • Amputation procedure with TMR and/or RPNI construction
  • Modified amputation procedure
Trial Overview The study tests a new way of performing lower limb amputations that could work better with advanced prosthetics. It aims to standardize this novel procedure for below knee (BKA) and above knee (AKA) amputations and improve motor control and sensory feedback in the residual limbs.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention
Modified amputation procedure

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Massachusetts Institute of Technology

Collaborator

Trials
104
Recruited
12,810,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Northwestern University

Collaborator

Trials
1,674
Recruited
989,000+

Findings from Research

Minor amputations aim to preserve as much of the foot and leg as possible to maintain a load-bearing extremity, which is crucial for mobility and function.
Longitudinal partial amputations of the forefoot and midfoot are particularly beneficial as they help maintain stability and balance while minimizing complications associated with reduced surface area and muscle imbalance.
[Minor amputations: a maxi task : Part 2: From transmetatarsal amputation to hindfoot amputation].Matamoros, R., Riepe, G., Drees, P.[2022]
Combining targeted muscle reinnervation (TMR) with regenerative peripheral nerve interface (RPNI) techniques (TMRpni) in a patient with a left above-the-knee amputation resulted in reduced phantom and nerve pain.
This innovative approach may enhance the quality of life for amputee patients as the technique gains wider acceptance and understanding in clinical practice.
Combined TMR and RPNI in a vasculopathy patient: A case report.Galbraith, LG., Najafali, D., Gatherwright, JR.[2023]
Targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) procedures significantly reduce pain scores in patients with symptomatic neuromas after amputation, with a mean pain score decrease from 4.3 to 1.7 points, and 92% of patients reporting resolution of nerve-related symptoms.
The study identified specific nerves, such as the sciatic nerve above the knee and the tibial nerve below the knee, that frequently require intervention for pain after amputation, suggesting that addressing these nerves during primary amputation can prevent future pain issues.
Practice Patterns and Pain Outcomes for Targeted Muscle Reinnervation: An Informed Approach to Targeted Muscle Reinnervation Use in the Acute Amputation Setting.Hoyt, BW., Gibson, JA., Potter, BK., et al.[2022]

References

Reoperation and Reamputation After Transmetatarsal Amputation: A Systematic Review and Meta-Analysis. [2022]
Risk factors for impaired wound healing and prolonged hospitalization in patients after amputation of the lower limb above the knee joint. [2022]
Outcome of Modified Pirogoff Amputation for Diabetic Foot Infection: A Single-Center Case Series. [2023]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
["Preliminary" amputation for the irreversible ischemia of the lower extremities]. [2022]
[Minor amputations: a maxi task : Part 2: From transmetatarsal amputation to hindfoot amputation]. [2022]
Combined TMR and RPNI in a vasculopathy patient: A case report. [2023]
Practice Patterns and Pain Outcomes for Targeted Muscle Reinnervation: An Informed Approach to Targeted Muscle Reinnervation Use in the Acute Amputation Setting. [2022]
TMRpni: Combining Two Peripheral Nerve Management Techniques. [2020]
9.North Macedoniapubmed.ncbi.nlm.nih.gov
Prophylactic Regenerative Peripheral Nerve Interfaces in Elective Lower Limb Amputations. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Peripheral Nerve Management in Extremity Amputations. [2022]
Our experience with modified osteomyoplasty for reamputation of war-related transtibial amputees. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Through-knee amputation in patients with peripheral arterial disease: a review of 50 cases. [2022]
Lower limb amputation in a general hospital: a comparative review. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Controversies in amputation surgery. [2022]
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