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RecruitingEarly Phase 1NCT07195461

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

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

Sponsor

MuscleMetrix, LLC

Enrollment

3 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Transtibial Amputee

Summary

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.

Eligibility

Min Age: 22 YearsMax Age: 65 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria14

  • 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.

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Interventions

DEVICEMagnetic Bead Tracking System

The Magnetic Beads will be implanted in a subject during either an already required revision of an existing unilateral or bilateral transtibial amputation or during the performance of a unilateral or bilateral transtibial amputation.

Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT07195461