eOPRA for Amputation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Cognitive impairment, Proximal nerve injury, Smoking, 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 tests a new implant system called e-OPRA, designed to improve comfort and control for individuals using myoelectric prostheses (artificial arms controlled by muscle signals) after an above-elbow arm amputation. The study will determine if the e-OPRA system, which does not require a tight arm-band for control, can enhance the comfort and stability of prosthesis use. It will also compare different configurations of the e-OPRA system, such as with or without sensory feedback, to identify the most effective setup. Individuals who have lost an arm above the elbow and use a muscle-controlled prosthetic arm may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could advance prosthetic technology for future users.

Do I need to stop my current medications for the eOPRA trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the e-OPRA device is safe for individuals with transhumeral amputations?

Research has shown that the OPRA implant system, similar to the eOPRA system, has been well-received in other studies. In one study with above-knee amputees, those using the OPRA system reported better function and quality of life over two years. The OPRA system requires two surgeries to attach the prosthetic directly to the bone, which has proven stable and offers good control of the prosthetic.

For the eOPRA system, which includes sensory feedback, early results suggest it might provide better control and comfort for users. This system is designed to give stable signals for controlling the prosthetic without needing extra equipment, like an arm-band, to detect muscle signals. Although large safety studies specifically for the eOPRA system are not yet available, the technology and methods it uses have been tested before and are generally considered safe.

Since this trial marks the first time the eOPRA system is being tested in humans, it aims to collect initial safety data. While some safety evidence exists from similar systems, the specific safety details of the eOPRA system are still being learned. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The eOPRA system is unique because it integrates advanced sensory feedback and myoelectric control into prosthetic limbs for amputees, offering a more natural and intuitive experience. Unlike traditional prosthetics that rely on surface electrodes, eOPRA uses implanted EMG systems to directly connect with muscles and nerves, providing more precise control. Researchers are especially excited about the sensory feedback feature, which could significantly improve the user's ability to feel and interact with their environment, enhancing overall quality of life. This approach aims to bridge the gap between artificial and natural limb function more closely than current options.

What evidence suggests that the eOPRA system is effective for transhumeral amputations?

Research has shown that the eOPRA system, which provides sensory feedback, improves amputees' control and comfort with prosthetic limbs. In this trial, participants may receive the eOPRA system with sensory feedback, expected to enhance benefits by helping users better sense their surroundings, making daily tasks easier. Alternatively, participants might receive the eOPRA system without sensory feedback or the OPRA implant system, which has improved amputees' function and quality of life over two years. Studies on similar prosthetic systems have demonstrated significant enhancements in users' quality of life by offering better control of artificial limbs. Overall, these findings suggest that the eOPRA system could be an effective choice for individuals with upper-arm amputations. ^{1 3 6 7 8}

Who Is on the Research Team?

Levi Hargrove, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for individuals with upper arm amputations who have undergone Targeted Muscle Reinnervation surgery and use a myoelectric prosthesis. The study aims to test the e-OPRA implant system's safety and its potential to improve prosthetic control and comfort.

Inclusion Criteria

Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes)

English speaking

I am between 18 and 70 years old.

Exclusion Criteria

Significant new injury that would prevent use of a prosthesis

Individuals with active implants

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations

4-6 weeks

Randomized Cross-over Study (Phase 1)

Compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR

3 months

Randomized Cross-over Study (Phase 2)

Compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• eOPRA

Trial Overview The trial tests the Electronic Osseoanchored Prostheses for Rehabilitation of Amputees (e-OPRA) with different configurations: with sensory feedback, without sensory feedback, and compared to OPRA. It involves surgeries followed by randomized cross-over studies in home settings.

How Is the Trial Designed?

Group I: eOPRA system with sensory feedback Experimental Treatment 1 Intervention

eOPRA implant system with sensory feedback and myoelectric prosthesis system.

Group II: eOPRA implant system Experimental Treatment 1 Intervention

eOPRA system with implanted EMG control and myoelectric prosthesis system.

Group III: OPRA implant system Active Control 1 Intervention

OPRA implant with surface EMG and myoelectric prosthesis system.

Group IV: eOPRA system without sensory feedback Active Control 1 Intervention

eOPRA implant system without sensory feedback and myoelectric prosthesis system.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Integrum

Industry Sponsor

Trials

8

Recruited

250+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40029529/

results from a two-year study of the OPRA implant system ... Conclusion: The OPRA implant system significantly improved functional outcomes and quality of life for transfemoral amputees over two years.

2. 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 ...

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

Osseointegration for Lower and Upper Limbs This implant system had a 2- and 5-year survival rate of 83 % and 80 %, respectively, in TH amputees, which appeared lower than the 2-year survival rate (92 %) ...

4. prnewswire.com prnewswire.com/news-releases/integrums-opra-implant-system-demonstrates-superior-treatment-outcomes-in-two-year-follow-up-study-by-walter-reed-national-military-medical-center-302404635.html

Integrum's OPRA™ Implant System demonstrates superior ... "This study confirms the safety, durability, and positive impact of the OPRA Implant System for individuals who have undergone amputation.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06391697

Magnetic Bead Tracking System and eOPRA Implant ... The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07032753?aggFilters=status%3A

Neuromusculoskeletal Interface for Bionic Arms The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems.

7. cureus.com cureus.com/articles/357066-investigating-the-feasibility-and-safety-of-osseointegration-with-neural-interfaces-for-advanced-prosthetic-control

Investigating the Feasibility and Safety of Osseointegration ... The modular OPRA implant system uses a two-stage surgical procedure where a titanium screw-like fixture is implanted within the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086952/

Investigating the Feasibility and Safety of Osseointegration ... The modular OPRA implant system uses a two-stage surgical procedure where a titanium screw-like fixture is implanted within the ...