e-OPRA Implant System for Lower Limb Amputees

Overseen By Matthew J Carty, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Integrum

Must not be taking: Corticosteroids, Immunosuppressants, Chemotherapy

Disqualifiers: Pregnancy, Tobacco use, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hugh M Herr, PhD

Principal Investigator

Massachusetts Insititute of Technology

Eligibility Criteria

This trial is for adults aged 22-65 who need a lower limb amputation and can walk at different speeds (K3 level). They must have enough healthy bone for the implant, not be pregnant or smoking, and have no severe health issues like diabetes or skin diseases. Participants should commit to follow-ups for two years after surgery.

Inclusion Criteria

My bones are strong enough to support an implant.

I have consulted with two specialists and a psychiatrist about saving my limb before considering amputation.

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

Exclusion Criteria

I have an active skin condition on the limb where surgery is planned.

I haven't taken steroids, immune-suppressants, or chemotherapy drugs in the last 6 months.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Implantation

Each subject undergoes surgery where the e-OPRA Implant System is implanted

1 week

Follow-up

Participants are monitored for safety and effectiveness after the implantation, with the last session occurring approximately 24 months after surgery

24 months

Treatment Details

Interventions

• e-OPRA Implant System

Trial Overview The e-OPRA Implant System is being tested on up to six people with leg amputations. It's an advanced prosthetic anchored directly into the bone that uses implanted electrodes for better control of the artificial limb. The study will check how well participants can use this new system over two years.

Participant Groups

Group I: e-OPRA Implant System Experimental Treatment 1 Intervention

Implantation of e-OPRA Implant System in lower limb.

Who Is Running the Clinical Trial?

Integrum

Lead Sponsor

Trials

8

Recruited

250+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+