ACTIVE_NOT_RECRUITING

Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees

Conditions

Amputation prosthesis osseointegration neural transmission magnetic beads

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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 e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The Magnetic Bead Tracking System, which will be implanted and used in combination with the e-OPRA Implant system, is an investigational device that consists of pairs of magnetic beads, and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time. When the beads are implanted in muscle in the residual limb of an amputee, the muscle length signal is communicated to an investigational, robotic ankle-foot prosthesis. The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of seven subjects will be enrolled. Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted. The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Official Title

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

Quick Facts

Study Start:2024-05-01

Study Completion:2027-05-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06391697

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
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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Matthew J Carty, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Hugh Herr, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

MIT Media Lab

Cambridge, Massachusetts, 02139

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Matthew J Carty, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
Hugh Herr, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology

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 Date2024-05-01

Study Completion Date2027-05-02

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2027-05-02

Terms related to this study

Keywords Provided by Researchers

prosthesis
osseointegration
neural transmission
magnetic beads

Additional Relevant MeSH Terms

Amputation