Osseointegrated Transtibial Prosthesis With Neural Interface

NCT05249049 | Unknown FDA Device

• 1 other identifier: 2012000283
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Amputation

Keywords

Osseointegration; Prosthesis; Neural Transmission

Outcome Measures

Primary Outcomes (3)

• Electrode Robustness and Connector/Lead Integrity (resistance)

  Measured Impedance of electrode(kOhms)

  24 months

• Electrode Robustness and Connector/Lead Integrity (amplitude)

  Maximal Voluntary Contraction Amplitude (mV)

  24 months

• Sensor Function and Signal Quality

  Signal-to-noise ratio (SNR) above 2

  24 months

Secondary Outcomes (1)

• Preferred Walking Speed

  24 months

Study Arms (1)

e-OPRA Implant System for Transtibial Amputees

EXPERIMENTAL

Implantation of e-OPRA Implant System in lower limb.

Device: e-OPRA Implant System for Transtibial Amputees

Interventions

e-OPRA Implant System for Transtibial Amputees DEVICE

The e-OPRA System for transtibial use consists of an anchorage element (Fixture), which is surgically inserted in the medullary canal of the amputated skeleton of the lower limb. The skin penetrating e-Abutment is then inserted and secured with the e-Abutment screw. To allow the system to be used with an external neuro-mechanical prosthesis, soft tissues from the distal limb are preserved incorporated into the residual limb. Muscle electrodes are then placed in the neuro-muscular constructs. After a rehabilitation program, in everyday use, the implanted e-OPRA device will be used by the patient with the Axor TC and their commercially available prosthesis. However, the modified version of the implant will allow the patient to use a powered neuro-mechanical prosthesis during specified testing scenarios.

Also known as: e-OPRA

e-OPRA Implant System for Transtibial Amputees

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead
• Brigham and Women's Hospital: collaborator
• Integrum: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

RECRUITING

Central Study Contacts

Hugh M Herr, PhD

CONTACT

617-314-3661; hherr@media.mit.edu

Matthew J Carty, MD

CONTACT

617-983-4555; mcarty@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: February 21, 2022
• Study Start: November 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 15, 2023
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

US (2)