Ossiofiber® Nail for Knee Stress Fractures

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

10 Participants Needed

Trial Summary

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.

Is the OSSIOfiber® Nail generally safe for use in humans?

The OSSIOfiber® Hammertoe Fixation Implant, a similar bio-integrative fiber-reinforced implant, was studied for joint correction and showed successful bio-integration at a 1-year follow-up, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is the OSSIOfiber® Nail treatment for knee stress fractures different from other treatments?

The OSSIOfiber® Nail is unique because it is made from a bio-integrative material that gradually incorporates into the bone, potentially reducing the need for future surgeries to remove the implant, unlike traditional metal nails. ^{6 7 8 9 10}

What is the purpose of this trial?

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because we are using the TFNs in the way they are intended to be used via FDA approval.

Research Team

Seth Sherman, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Subchondral Insufficiency Experimental Treatment 1 Intervention

Those who have subchondral insufficiency with tibial or femoral overload in the knee.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

NuGen Fx bioabsorbable screws: a preliminary report of their use in foot surgery. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Fluoroscopy-guided reduction and fibular nail fixation to manage unstable ankle fractures in patients with diabetes: a retrospective cohort study. [2017]

3. France pubmed.ncbi.nlm.nih.gov

Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows implant bio-integration at 1-year follow-up. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Optimizing Long-Term Outcomes and Avoiding Failure With the Fibula Intramedullary Nail. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

["Biorigid" interlocking after unreamed intramedullary nailing of tibial shaft fractures]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Intramedullary nailing of the tibia without a fracture table: the transfixion pin distractor technique. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Recommendations for avoiding knee pain after intramedullary nailing of tibial shaft fractures. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Incidental Asymptomatic Fibular Stress Fractures Presenting as Varus Knee Osteoarthritis: A Case Report. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Fatigue stability of locking screws for unreamed tibial intramedullary nailing]. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Treatment of closed tibial fractures. [2005]