CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Modified amputation procedureprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03374319
NCT03374319N/ACompleted

Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations

Brigham and Women's Hospital·interventional·Posted Dec 15, 2017·Updated Oct 20, 2025

In Brief

A clinical study evaluating Modified amputation procedure for Amputation. Completed, enrolled 50 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 15, 2017
Enrollment StartSep 15, 2017
Primary CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 8.5 years ago

Interventions

Modified amputation procedureprocedure

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.