Status:
UNKNOWN
Osseointegrated Transtibial Prosthesis With Neural Interface
Lead Sponsor:
Massachusetts Institute of Technology
Collaborating Sponsors:
Brigham and Women's Hospital
Integrum
Conditions:
Amputation
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
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 direc...
Detailed Description
Normalization of function for individuals with limb amputation is within reach, and will be achieved by smart implants capable of bi-directional communication between brain and machine via bone-anchor...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05249049
Start Date
November 3 2021
End Date
April 15 2023
Last Update
February 21 2022
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
MIT Media Lab
Cambridge, Massachusetts, United States, 02139