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Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

NCT03374319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-17

No results posted yet for this study

Summary

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

Conditions

  • Amputation

Interventions

PROCEDURE

Modified amputation procedure

A stair-step (BKA) or fishmouth (AKA) incision will be made. Tibial and fibular or femoral osteotomies will be performed. Segments of the tibialis anterior (TA), peroneus longus (PL), lateral gastrocnemius (LG) and tibialis posterior (TP) muscles will be isolated, as well as the quadriceps (Q) and hamstring (H) groups in the AKA model; if it is not possible to preserve native innervation to these muscles, functional motor units will be constructed from muscle coapted to the appropriate motor nerve endings. The distal tibial and peroneal nerves will be redirected to skin patches in the distal or proximal thigh. Coaptation of the TA/LG, PL/TP and Q/H muscles will then be performed to promote dynamic coupling of these agonist/antagonist pairs. The skin envelope will then be closed in layers over percutaneous drains.

Sponsors & Collaborators

Principal Investigators

  • Matthew J Carty, MD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374319 on ClinicalTrials.gov