Magnetic bead tracking and bionic prosthesis for amputees

A Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Efficacy When Used with the E-OPRA Implant System and a Bionic External Prosthesis to Improve Prosthetic Controllability for Persons with Transtibial Amputation

This study is testing a new system that helps people with leg amputations control their prosthetic limbs better and move more comfortably by using special implants and magnetic technology.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT06391697 on ClinicalTrials.gov

What this trial studies

This study evaluates the e-OPRA Implant System, which provides direct skeletal anchorage for prosthetic limbs, enhancing control through implanted electrodes that facilitate communication between the brain and the prosthesis. The Magnetic Bead Tracking System, used alongside the e-OPRA Implant, employs magnetic beads to monitor muscle length and movement speed in real-time. This innovative approach aims to improve the rehabilitation of transtibial amputees by eliminating the need for external sockets, thereby reducing pain and enhancing mobility. The study focuses on individuals with high physical activity levels who have undergone amputation due to trauma or cancer.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 22-65 with a unilateral or bilateral transtibial amputation or those requiring such an amputation with sufficient residual tibia.

Not a fit: Patients who do not meet the eligibility criteria or those with lower functional levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the quality of life and mobility for transtibial amputees.

How similar studies have performed: Previous studies on osseointegration and neuroprosthetics have shown promising results, indicating potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Male or Female age 22-65 at the time of surgery.
2. The subject must already have been implanted with the e-OPRA Implant System at the transtibial level or must have an existing unilateral or bilateral transtibial amputation or a medical condition requiring performance of a unilateral or bilateral transtibial amputation with a minimum of 8 cm of residual tibia after amputation, such that the subject will be implanted with the e-OPRA Implant System. (OPTION 1)
3. If the subject does not already have the e-OPRA Implant System, the subject must have undergone independent consultation with at least two lower extremity surgical specialists 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. (OPTION 2)
4. The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as confirmed by study investigators).
5. The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.
6. In the opinion of the investigator, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate.
7. Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
8. Willingness and ability to provide informed consent to participate in the study.

Exclusion Criteria:

1. Subjects with any active skin disease in the tested limb.
2. Subjects with severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life. expectancy, vulnerable patient population, BMI \>40, etc.).
3. For subjects who have not yet been implanted with the e-OPRA Implant System, subjects who would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
4. Subjects with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb.
5. Subjects 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 subject to be a good study candidate.
6. Subjects with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
7. Subjects with a known need of future MRIs.
8. Subjects currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.
9. 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.
10. Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
11. Subject has an allergy to any component of the device.
12. Concurrent illness, disability or geographical residence would hamper attendance at required study visits.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• MIT Media Lab — Cambridge, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Matthew J Carty, MD — Brigham and Women's Hospital
• Study coordinator: Matthew J Carty, MD

Conditions Amputation; prosthesis; osseointegration; neural transmission; magnetic beads