Ossiofiber® Nail for Knee Stress Fractures

Enrolling by invitation at 1 trial location

Overseen By Elizabeth Jameiro, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Tobacco use, Substance abuse, Diabetes, High surgical risk, others

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

Compensation: Varies

Number of Visits: 7

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for knee stress fractures using special fixation nails made from OSSIOfiber®. The goal is to determine if these nails improve knee pain and function in individuals with subchondral insufficiency, a condition where the bone beneath the knee cartilage weakens. The trial targets those who have experienced knee pain for at least three months and are considering knee arthroscopy due to issues like a meniscal tear. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future treatment options for knee conditions.

Will I have to stop taking my current medications?

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 OSSIOfiber® Trimmable Fixation Nails are safe for treating knee stress fractures?

Research has shown that OSSIOfiber® Trimmable Fixation Nails are generally well-tolerated by patients. In past studies, using these nails for knee problems, such as certain types of bone weakness, led to less pain and improved movement. This suggests the treatment is safe for most people.

These nails are bio-integrative, meaning they work well with the body's natural healing processes. They assist bones in healing and staying in place without causing major side effects. The FDA has already approved OSSIOfiber® Nails for similar uses, further supporting their safety. While no treatment is completely risk-free, current evidence suggests these nails are generally safe and effective for knee issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OSSIOfiber® Trimmable Fixation Nails are unique because they are designed to integrate naturally into the bone over time, unlike traditional metal hardware. These nails are made from a composite material that encourages bone growth, which means they can potentially provide better long-term outcomes for knee stress fractures due to subchondral insufficiency. Researchers are excited about this treatment because it offers the possibility of reducing the need for future surgeries to remove hardware, enhancing overall recovery and mobility for patients.

What evidence suggests that OSSIOfiber® Trimmable Fixation Nails are effective for subchondral insufficiency?

Research has shown that OSSIOfiber® Trimmable Fixation Nails, which participants in this trial will receive, can effectively treat knee issues caused by weakened bone. Studies have found that patients using these nails experienced less pain and improved knee function. All patients returned to sports without needing additional surgeries or experiencing implant problems. These nails align and stabilize broken bones, aiding in healing. Overall, this treatment has shown promising results in improving outcomes for knee stress fractures. ^{1 2 3 4 6}

Who Is on the Research Team?

Seth Sherman, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with knee pain lasting over 3 months who are candidates for knee arthroscopy due to issues like meniscal tear or loose body. It's not suitable for current or recent tobacco users, those with substance abuse history, uncontrolled diabetes, high surgical risk, pregnancy plans before surgery, active infections in the knee, or if additional procedures on the knee are needed.

Inclusion Criteria

I have had knee pain for at least 3 months.

I need knee surgery for a tear or other knee issues.

Exclusion Criteria

Substance abuse history

I currently use tobacco or quit less than 3 months ago.

My diabetes is not well-controlled (HbA1c>8).

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 treating subchondral insufficiency of the knee

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee ligament healing and patient-reported outcomes

24 months

Multiple visits (in-person) at 6, 12, and 24 months

Long-term follow-up

Extended monitoring of knee health and function, including incidence assessments of re-operations or additional management

Up to 24 months post-operatively

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 manage subchondral insufficiency of the knee. The goal is to see if this treatment improves patient-reported outcomes and imaging findings related to stress fractures under FDA-approved usage.

How Is the Trial Designed?

Group I: Subchondral Insufficiency Experimental Treatment 1 Intervention

Those who have subchondral insufficiency with tibial or femoral overload in the knee and are receiving the TFNs as standard of care.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

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

Biointegrative Nail Raftering Improves Pain and Function in ... All patients reported successful return to sport, with no reoperations or implant failures. Conclusions: Biointegrative fixation nail raftering for treatment of ...

2. 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- ...

3. 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.

4. ctv.veeva.com ctv.veeva.com/study/bio-integrative-fiber-reinforced-kneebar-for-treating-subchondral-insufficiency-of-the-knee-1

Bio-Integrative, Fiber-Reinforced Kneebar for Treating ... The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts.

5. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/STUDY00002986

Bio-Integrative, Fiber-Reinforced Kneebar for Treating ... The purpose of the study is to determine whether the use of the OSSIOfiber Trimmable Fixation Nails for treating subchondral insufficiency fractures of the knee ...

6. 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 ...