Modified Amputation Procedure for Lower Limb Amputations
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?
Is the modified amputation procedure with TMR and RPNI safe for humans?
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo a modified amputation procedure incorporating innervated muscle segments for enhanced prosthetic control
Acute Postoperative Rehabilitation
Development and implementation of a modified acute postoperative rehabilitation strategy suited to the new surgical approach
Follow-up
Participants are monitored for motor unit excursion, proprioception recovery, and other postoperative outcomes
Treatment Details
Interventions
- Amputation procedure with TMR and/or RPNI construction
- Modified amputation procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborator
Massachusetts Institute of Technology
Collaborator
University of Michigan
Collaborator
Northwestern University
Collaborator