Actively Recruiting
A Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Effectiveness With a Bionic External Prosthesis to Improve Prosthetic Control for Transtibial Amputation
Led by MuscleMetrix, LLC · Updated on 2025-09-26
3
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the Magnetic Bead Tracking System for controlling a powered ankle-foot prosthesis in people with transtibial amputation. This early feasibility study involves up to five participants, each serving as their own control to compare prosthetic gait performance using the Magnetic Bead Tracking System with an intrinsic robotic controller. The system tracks muscle length and speed in real-time to help improve the natural control of prosthetic limbs. Participants will receive the Magnetic Bead Tracking System, which uses pairs of implanted magnetic beads and external sensors to measure muscle movements in the residual limb. This muscle length data guides the robotic prosthesis to provide intuitive and simultaneous position and torque control. The study includes surgical implantation of the beads during amputation or revision surgery and compares performance using both the new system and the standard robotic controller. Throughout the study, participants will undergo assessments including walking speed, obstacle course timing, gait symmetry, musculoskeletal stress, pain levels, and overall mobility. Safety is closely monitored by tracking any adverse events and performing regular limb examinations. Data will be collected over several visits up to 6 months after implantation to evaluate the device's effects on prosthetic control and participant outcomes.
CONDITIONS
Brief Title
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 22 to 65 years at the time of surgery
- Existing unilateral or bilateral transtibial amputation requiring revision, or planned unilateral or bilateral transtibial amputation
- If no prior amputation, must have consulted a lower extremity surgical specialist and undergone psychiatric and pain evaluations
- Ability to walk at variable speeds with expected prosthesis functional level of K3 or above
- Adequate soft tissue bulk and muscle mass in the operative limb for wound healing
- Demonstrated voluntary muscle activation where magnets will be implanted
- Likely able to tolerate prosthetic socket pressure during walking, as determined by investigator
- No physical limitations, addictive diseases, or medical conditions preventing study participation
- Willingness and ability to participate in all study evaluations and provide informed consent
You will not qualify if you...
- Active skin disease in the limb to be studied
- Severe other medical conditions or poor physical/mental health preventing study participation
- Active infection, metabolic bone disease, or metastatic lesions in residual tibia
- Weight over 285 lbs with prosthesis at screening
- Skeletal growth not complete as shown by X-ray
- Severe muscle atrophy or poor soft tissue coverage in operative limb
- Severe peripheral vascular disease, diabetes, neuropathy, severe phantom pain, or osteoporosis preventing study eligibility
- History of corticosteroids, immune-suppressive therapy, or chemotherapy within 6 months before surgery
- Known need for future MRI scans
- Participation in another conflicting clinical study
- Active smoking or unwillingness to cease tobacco use 6 weeks before surgery
- Pregnancy, lactation, or planning pregnancy within 12 months post-surgery
- Allergy to any device component
- Illness, disability, or location preventing attendance at study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants will have magnetic beads implanted during a transtibial amputation or revision surgery to enable control of a bionic external prosthesis.
1 surgical visit (in-person)
Duration - Up to 6 months
Participants will use the Magnetic Bead Tracking System with a powered ankle prosthesis to evaluate improved prosthetic control and gait performance.
Visits as needed for prosthetic use and assessments
Duration - Up to 6 months post-implantation
Participants will be monitored for safety, device performance, and adverse events with assessments including walking speed and obstacle course speed.
Multiple visits up to 6 months
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
D
Deborah Grayeski, JD
K
Kendall Program Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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