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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new implant system designed to improve the control and functionality of prosthetic limbs for lower limb amputees. The e-OPRA Implant System connects directly to the skeleton and uses electrodes to enhance communication between the prosthetic and the body, aiming to provide users with full neural control over their artificial limb. The trial seeks participants who have undergone a transfemoral amputation (above the knee) and can walk at different speeds without assistance. Participants should have tried all other limb-saving options and be in good health otherwise.

As an unphased trial, this study offers an opportunity to contribute to groundbreaking research that could enhance prosthetic technology for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been on corticosteroids, immune-suppressive therapy, or chemotherapy drugs within six months before the surgery, you may not be eligible to participate.

What prior data suggests that the e-OPRA Implant System is safe for lower limb amputees?

Research has shown that the original OPRA Implant System, which the e-OPRA builds upon, has been used for over ten years with good results. A study that tracked patients for a decade found that the system was generally well-tolerated. However, there is a 9% chance of a serious infection that might require implant removal.

The e-OPRA Implant System includes new electrodes to enhance prosthetic function. Although these electrodes are new, the basic design of the implant has a proven safety record from the original OPRA system. As the e-OPRA is an updated version of an already approved device, it suggests similar safety. However, as with any new technology, unknown risks may still exist. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The e-OPRA Implant System is unique because it offers a new approach for lower limb amputees by integrating an implanted system directly with the bone, muscle, and nerves. Unlike conventional prosthetics that rely on external sockets, this system aims for a more natural connection and improved control of the prosthetic limb. Researchers are excited about this treatment because it has the potential to enhance mobility and provide users with a better sense of feeling and control, which could significantly improve the quality of life for amputees.

What evidence suggests that the e-OPRA Implant System is effective for lower limb amputees?

Research has shown that the OPRA Implant System, which the e-OPRA builds on, offers promising long-term results for people with lower leg amputations. In a study with at least a 9-year follow-up, users of the OPRA system reported improved mobility and quality of life. In this trial, participants will receive the e-OPRA Implant System, which enhances the original by adding a two-way interface. This allows users to control the prosthetic limb more effectively through stable bioelectric signals. As a result, users might control the prosthetic with their nerves, leading to more natural movement. Although long-term data on the e-OPRA is limited, its design aims to significantly improve prosthetic control and user experience. ^{1 2 3 4 5}

Who Is on the Research Team?

Hugh M Herr, PhD

Principal Investigator

Massachusetts Insititute of Technology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9588992/

Osseointegrated prostheses for the rehabilitation of patients ... This study reports the ten-year results from the first-ever prospective study following individuals with TFAs being supplied with bone-anchored ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06391697

Magnetic Bead Tracking System and eOPRA Implant ... 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 ...

3. aetna.com aetna.com/cpb/medical/data/1000_1099/1045.html

Osseointegration for Lower and Upper Limbs These investigators reported outcome data for the United Kingdom Trial of the OPRA Implant System with a minimum of 9-year follow-up. A total of 18 TF amputees ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666769X2300009X

Osseointegration for amputees: Current state of direct ... The 10-year cumulative risk of deep infection leading to removal of the implant is reported 9% for the OPRA [39], although long-term data on other OI implants ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190009B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The OPRATM Implant System is indicated for patients who have transfemoral amputation due to trauma or cancer and who have or are anticipated to ...