Fiber-Reinforced Kneebar for Bone Marrow Edema

Overseen By Lindsey Agnew, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Rheumatoid arthritis, Diabetes, Tobacco use, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OSSIOfiber® Trimmable Fixation Nails for knee pain caused by bone marrow edema (swelling in the bone). The goal is to determine if these special nails, designed to support bone healing, can improve patients' symptoms and knee appearance on scans. Candidates include those with knee pain for at least three months, specific types of arthritis, and no steroid injection in the past three months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to developing a potentially effective solution for knee pain.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have had a steroid injection or any other non-surgical intervention in the study knee for at least 3 months before joining the trial.

What prior data suggests that the OSSIOfiber® Trimmable Fixation Nails are safe for treating subchondral insufficiency of the knee?

Research has shown that OSSIOfiber® Trimmable Fixation Nails are generally safe for use in bone surgeries. These nails support bones as they heal naturally. However, some side effects have been reported. In a few cases, patients experienced swelling and discomfort at the site of nail placement. For instance, one patient required nail removal six months post-surgery due to these issues. Considering these possible side effects is important when deciding to join a clinical trial. The treatment has been used in many surgeries, suggesting it is usually well-tolerated, but like any medical procedure, risks exist. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for bone marrow edema, which often rely on rest, medication, or surgical interventions, OSSIOfiber® Trimmable Fixation Nails offer a unique approach by using bio-integrative material. This material naturally integrates with the bone over time, potentially reducing the need for hardware removal surgeries. Researchers are excited because this could mean less invasive procedures and a smoother recovery process for patients. Additionally, the ability to trim the fixation nails allows for more tailored and precise treatment options, which could improve overall outcomes.

What evidence suggests that the OSSIOfiber® Trimmable Fixation Nails are effective for bone marrow edema?

Research has shown that OSSIOfiber® Trimmable Fixation Nails can reduce pain and improve movement in people with knee problems. Patients who used this treatment reported less pain and improved mobility. The nails naturally integrate with the bone, aiding the body's healing process. They offer stable support, which facilitates knee healing. These findings suggest that this treatment could effectively address knee issues related to bone marrow swelling. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with a BMI under 40, experiencing knee pain due to conditions like meniscal tears or osteoarthritis. Participants must have confirmed bone marrow lesions in the knee and not received steroid injections for at least 3 months. They should be able to attend follow-up visits and complete questionnaires.

Inclusion Criteria

Body Mass Index < 40

Agree to study participation and consent obtained

I need knee surgery due to a tear or other knee issues.

Exclusion Criteria

Currently pregnant or has plans to become pregnant prior to surgery

Current tobacco use or has quit within 3 months of study enrolment

Substance abuse history

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of bio-integrative OSSIOfiber® Trimmable Fixation Nails for the management of subchondral insufficiency

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of KOOS and other outcome measures

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• OSSIOfiber® Trimmable Fixation Nails

Trial Overview The study tests OSSIOfiber® Trimmable Fixation Nails used in a specific pattern within the tibia or femur to treat subchondral insufficiency of the knee. The goal is to see if this treatment improves patient-reported outcomes and imaging results compared to standard care.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06423378

Bio-Integrative, Fiber-Reinforced Kneebar for Treating ... The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X25000318

Biointegrative Nail Raftering Improves Pain and Function in ... Biointegrative fixation nail raftering for treatment of subchondral insufficiency of the knee resulted in improved patient-reported pain and functionality.

3. withpower.com withpower.com/trial/phase-2-fractures-stress-5-2024-e3e81

Fiber-Reinforced Kneebar for Bone Marrow Edema The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi- ...

4. withpower.com withpower.com/trial/phase-fractures-stress-10-2023-8a896

Ossiofiber® Nail for Knee Stress Fractures The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi- ...

5. ossio.io ossio.io/products/trimmable-fixation-nail-family/trimmable-fixation-nails/

OSSIOfiber® Trimmable Fixation Nails Our unique Trimmable Nail enables all-natural healing and utility in a wide range of surgical applications with the added convenience of sterile, disposable ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=13152570&pc=HTY

MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER ... Company was notified of a removal surgery following swelling and discomfort in the foot 6 months after implantation.

7. ossio.io ossio.io/wp-content/uploads/2025/05/Ossio-Pilot-PDF-In-Press.pdf

Biointegrative Nail Raftering Improves Pain and Function in ... This mechanical over- load of the tibiofemoral joint can lead to bone marrow edema, which is strongly associated with knee pain in patients with OA.8-10 Such ...

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=14239978&pc=HTY

MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER ... Swelling was attributed to the unstable fixation of the surgical site.Removal surgery was performed successfully the following week.The actual device could not ...