Clinical trial NCT03720171: e-OPRA Implant System for Lower Limb Amputees
Official title: An Osseointegrated Transfemoral Prosthesis Study Evaluating Stable Neural Signal Transmission in Patients With Transfemoral Amputations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: Osseointegration
Bone-anchored prosthesis
Neuro-prosthesis
Lead sponsor: Integrum
Sponsor class: INDUSTRY
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts Institute of Technology
First posted: 2018-10-25
Enrollment: 2
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, uncontrolled study.
Primary purpose: TREATMENT

Brief summary: The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004. 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 lower limb amputee with the e-OPRA Implant System exhibiting full neural control over a neuro-mechanical prosthetic system.

A maximum of six 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.


Eligibility criteria: Inclusion Criteria:

A potential subject will be included in the study if she/he meets all of the following inclusion criteria:

* Male or Female age 22-65 at the time of surgery.
* The patient must have a medical condition requiring performance of a unilateral transfemoral amputation with a minimum of 13 cm of residual femur after amputation, and:

A: At a minimum level of amputation of 20 cm or greater above the knee joint line if physical therapy and prosthetist evaluation is commensurate with a standard K3 ambulatory status; or, B: At a minimum level of amputation of 16 cm above the knee joint line as part of a single-stage procedure if physical therapy and prosthetist evaluation is commensurate with a more active K3 or less active K4 postoperative ambulatory status.

* 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.
* In the opinion of the investigators, 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 Criteria:

* 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.
* Active infection or dormant bacteria.
* Subjects would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
* 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 patient 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.

Primary outcomes:
measure: Electrode function
timeFrame: 24 months
Secondary outcomes:
measure: Preferred walking speed
timeFrame: 24 months
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: MIT Media Lab
state: Massachusetts
Study officials:
affiliation: Massachusetts Insititute of Technology
name: Hugh M Herr, PhD
role: PRINCIPAL_INVESTIGATOR
References: