Recruiting
Early Phase 1

Magnetic Bead Tracking

Sponsor:

MuscleMetrix, LLC

Code:

NCT07195461

Conditions

Transtibial Amputee

Transtibial Amputation

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Magnetic Bead Tracking System

Study Details

Brief 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.

Conditions

Transtibial Amputee

Transtibial Amputation

Study ID

NCT07195461

Start date

Sep 11, 2025

Status verified date

Sep, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transtibial amputees

Up to five subjects signing an informed consent and meeting all inclusion and exclusion criteria will be enrolled into the study to receive the Magnetic Bead Tracking System. Each subject will serve as their own control in a repeated measures ('within subjects') design. During experimentation, each subject will have prosthetic gait performance measured while using the Magnetic Bead Tracking System compared to an intrinsic robotic controller.

Interventions

Magnetic 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.

Primary outcome measure

  • Walking Speed [ Time Frame: One timepoint, between days 150-180. ]
  • Obstacle course speed [ Time Frame: One timepoint, between days 150-180. ]

Central Contacts and Locations

Central contacts

Deborah Grayeski, JD

202-550-7395deborah.grayeski@gmail.com

Kendall Program Manager

kclites@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kendall Program Manager

512-538-8297kclites@mgb.org

Principal Investigator:

Matthew J Carty, M.D.

More Information

Sponsor

MuscleMetrix, LLC

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • transtibial
  • amputation
  • amputee
  • magnet
  • prosthesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MuscleMetrix, LLC on 2025-09-26.