OPRA Prosthetic Device for Below Knee Amputation

(TOSS Trial)

Recruiting at 1 trial location

Overseen By Emma M Stewart

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Walter Reed National Military Medical Center

Disqualifiers: Osteoporosis, BMI over 35, others

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

Compensation: Varies

Number of Visits: 9

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prosthetic device called the OPRA implant for individuals with lower leg loss (transtibial amputation) who struggle with traditional socket prostheses. The goal is to determine if this implant reduces complications like infections and improves mobility, quality of life, and overall comfort. Participants will undergo two surgeries to receive the implant and will be monitored over several years to assess improvements. This trial suits military healthcare beneficiaries aged 22–65 who find conventional prostheses uncomfortable or ineffective. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance prosthetic options for many.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What prior data suggests that the OPRA prosthetic device is safe for individuals with transtibial amputations?

A previous study found the OPRA prosthetic device to be generally safe and well-tolerated. In use since 1990, it has had only a few reported complications, indicating that serious side effects are uncommon. Research shows a low infection rate, which is a positive safety indicator. The FDA has approved the device for use in above-the-knee amputations, suggesting confidence in its safety for other applications. Overall, past data and experiences support the OPRA device's safety history. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional prosthetics for below-knee amputations, which typically rely on sockets that fit over the residual limb, the OPRA prosthetic device is unique because it directly connects to the bone through osseointegration. This method involves surgically implanting a titanium fixture into the bone, allowing for a more secure and stable attachment. Researchers are excited about this treatment because it has the potential to improve mobility, comfort, and control for amputees, reducing issues like skin irritation and discomfort commonly associated with socket prostheses.

What evidence suggests that the OPRA prosthetic device is effective for below knee amputation?

Research has shown that the OPRA prosthetic device, which participants in this trial will receive, can improve quality of life and function for people with amputations. Studies have found that patients using this device often experience better movement and greater satisfaction compared to those using traditional socket prostheses. In use since 1990, the device is generally safe, with few complications. Patients consistently report significant improvements in daily activities and comfort. These findings suggest that the OPRA prosthetic device effectively enhances the lives of people with lower limb amputations. ^{1 2 3 6 7}

Who Is on the Research Team?

Ashley Bee Anderson, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

This trial is for male and female military health care beneficiaries aged 22 to 65 with a below-knee amputation. It's not specified who can't join, but typically those with additional health issues or conditions that could interfere with the study might be excluded.

Inclusion Criteria

Eligible to receive care at Military Treatment Facility

DEERS-eligible

I am between 22 and 65 years old with a below-the-knee amputation.

Exclusion Criteria

The patient is not expected to be able to comply with treatment and follow up requirements

The patient's skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray

I am between 22 and 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 months

1 visit (in-person)

Surgery Stage I

Initial surgical procedure to implant the OPRA device into the intramedullary canal of the tibia

Immediate postoperative period

1 visit (in-person)

Surgery Stage II

Second surgical procedure to adjust and finalize the implant placement

3-6 months after Stage I

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Regular visits at 6, 12, 24, 36, 48, and 60 months post-Surgery Stage II

What Are the Treatments Tested in This Trial?

Interventions

• OPRA

Trial Overview The trial tests OPRA Osseointegration (OI) in individuals with transtibial amputations over four years. It aims to assess soft tissue complications, improvements in function, quality of life, pain reduction, physical performance enhancements, and changes in bone quality due to the implant.

How Is the Trial Designed?

Group I: OPRA implant leg Experimental Treatment 1 Intervention

The participants will have two stage surgical procedures to implant the OPRA device to the amputated leg.

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Published Research Related to This Trial

The Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) offers improved function and quality of life for patients with extremity amputations compared to traditional socket prosthetics, as demonstrated in clinical trials.

The OPRA implant has a long lifespan and a low complication rate, making it a promising option for enhancing rehabilitation in amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osseointegrated prostheses for the rehabilitation of amputees (OPRA): results and clinical perspective. Hoyt, BW., Walsh, SA., Forsberg, JA.[2020]

A structured protocol for testing lower limb prostheses emphasizes safety, requiring users to meet specific graded safety levels before progressing to more challenging environments.

This approach aims to reduce the risk of falls and injuries, thereby enhancing user confidence and overall experience with active prosthetic legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. Thesleff, A., Ahkami, B., Anderson, J., et al.[2022]

Osseointegrated prostheses provide significant advantages over traditional socket suspension methods, including better weight bearing, improved joint motion, and enhanced sensory feedback for amputees.

The OPRA program has developed specific surgical techniques and rehabilitation protocols for various types of amputations, showing promising long-term results for patients with transradial, transhumeral, and transfemoral amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osseointegrated prostheses for rehabilitation following amputation : The pioneering Swedish model. Li, Y., Brånemark, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6939984/

Osseointegrated Prosthetic Implants for People With Lower ... Three studies reported data from the Questionnaire for Persons with a Transfemoral Amputation, a self-reported outcome measure designed for above-the-knee ...

2. withpower.com withpower.com/trial/phase-transtibial-amputation-age-22-65-4-2025-1f675

OPRA Prosthetic Device for Below Knee Amputation The OPRA prosthetic device has been shown to be generally safe with a low complication rate. It has been used since 1990, and improvements in the rehabilitation ...

3. 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 ...

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

Osseointegration for amputees: Current state of direct ... Compelling evidence now demonstrates consistent and significant improvements in patient reported outcomes and quality of life as well as functional outcome ...

5. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/91023-patient-outcomes-in-a-novel-osseointegrated-device-for-transfemoral-amputation-a-case-series

Patient Outcomes in a Novel Osseointegrated Device for ... This study found the custom OI device to be safe and effective in the management of TFA in patients with controlled indications.

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

Osseointegration for Lower and Upper Limbs In a systematic review, these investigators examined the use, safety in terms of rate of infection and complications, and reported outcomes of upper and lower ...

7. 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 ...