Osseointegrated Transtibial Prosthesis With Neural Interface

Status unconfirmed · Not applicable

Conditions studied: Amputation

In brief

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 purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of two subjects will be enrolled. Each subject will undergo a surgery where the e-OPRA Implant System will be implanted. The subjects will participate in follow-up sessions of which the last one occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.

Key facts

Study ID

NCT05249049

Run by

Massachusetts Institute of Technology

People needed

2

Starts

2021-11-03

Expected to finish

2023-04-15

Last updated by the study team

2022-02-21

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female age 22-65 at the time of surgery.
• The patient 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.
• 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.
• The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
• The patient must have adequate bone stock to support the implanted device.
• The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing and muscle end organ construction.
• In the opinion of the investigator, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
• Written informed consent to participate in the study provided by the patient or legal representative.

You may not qualify if…

• Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
• Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
• Subjects who weigh over 90 kg.
• Subjects who have an active infection or dormant bacteria.
• Subjects would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
• Subjects with advanced atrophic muscle and and/or compromised soft tissue coverage in the operative limb.
• 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.
• Evidence of any active skin disease involving the proposed surgical limb.
• History of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
• 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.).
• The subject is currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.

Where it is running

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

Full record on ClinicalTrials.gov

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