RECRUITING

Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis

Conditions

Transtibial Amputee Transtibial Amputation transtibial amputation amputee magnet prosthesis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.

Official Title

A Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Effectiveness When Used With a Bionic External Prosthesis to Improve Prosthetic Controllability for Persons With Transtibial Amputation

Quick Facts

Study Start:2025-09-11

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07195461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or Female age 22-65 at the time of surgery. * The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation. * If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition, and a pain medicine evaluation to ensure that all pain control options outside of amputation have been addressed. * The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study investigators, through use of a patient history and physical examination). * The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing. * The patient must demonstrate volitional activation of the muscles into which magnet placement is intended. * In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively. * In the opinion of the investigator, the patient must have absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate. * The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. * The patient must have willingness and ability to provide informed consent to participate in the study.	* Patients with any active skin disease in the subject limb. * Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the patients to be a good study candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life. expectancy, vulnerable patient population, etc.). * Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and/or metastatic lesions in the residual tibia. * Patients weighing over 285 lbs. with the prosthesis, at time of screening. * Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray. * Patients with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb. * Patients with evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the patient to be a good study candidate. * Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery. * Patients with a known need of future MRIs. * Patients currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study. * Active smokers will be excluded from candidacy; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively. * Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up. * Patient having an allergy to any component of the device. * Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.

Inclusion Criteria

Exclusion Criteria

* Male or Female age 22-65 at the time of surgery.
* The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation.
* If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition, and a pain medicine evaluation to ensure that all pain control options outside of amputation have been addressed.
* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study investigators, through use of a patient history and physical examination).
* The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.
* The patient must demonstrate volitional activation of the muscles into which magnet placement is intended.
* In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively.
* In the opinion of the investigator, the patient must have absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate.
* The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
* The patient must have willingness and ability to provide informed consent to participate in the study.

* Patients with any active skin disease in the subject limb.
* Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the patients to be a good study candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life. expectancy, vulnerable patient population, etc.).
* Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and/or metastatic lesions in the residual tibia.
* Patients weighing over 285 lbs. with the prosthesis, at time of screening.
* Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.
* Patients with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb.
* Patients with evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the patient to be a good study candidate.
* Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
* Patients with a known need of future MRIs.
* Patients currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.
* Active smokers will be excluded from candidacy; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively.
* Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
* Patient having an allergy to any component of the device.
* Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.

Contacts and Locations

Study Contact

Deborah Grayeski, JD

CONTACT

202-550-7395

deborah.grayeski@gmail.com

Kendall Program Manager

CONTACT

kclites@mgb.org

Principal Investigator

Matthew J. Carty, M.D.

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: MuscleMetrix, LLC

Matthew J. Carty, M.D., PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-11

Study Completion Date2026-04

Study Record Updates

Study Start Date2025-09-11

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

transtibial
amputation
amputee
magnet
prosthesis

Additional Relevant MeSH Terms

Transtibial Amputee
Transtibial Amputation