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

Trial Summary

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 data supports the effectiveness of the Fiber-Reinforced Kneebar treatment OSSIOfiber® Trimmable Fixation Nails for Bone Marrow Edema?

The research on intramedullary nails, like the Fixion nail, shows that these types of treatments can stabilize fractures effectively, allowing for partial weight-bearing in about a week and full weight-bearing in about 40 days. This suggests that similar stabilization techniques, like the OSSIOfiber® nails, could be effective in treating bone conditions such as bone marrow edema. ^{1 2 3 4 5}

Is the Fiber-Reinforced Kneebar for Bone Marrow Edema safe for humans?

Research on similar fiber-reinforced implants in animals showed they were safe, with no adverse tissue reactions and complete absorption over time. These implants were well-integrated into the bone, suggesting they are generally safe for use. ^{6 7 8 9 10}

How is the OSSIOfiber® Trimmable Fixation Nails treatment unique for bone marrow edema?

The OSSIOfiber® Trimmable Fixation Nails are unique because they are made from a bio-integrative, fiber-reinforced material that allows for complete absorption and integration into the bone over time, unlike traditional metal implants that remain in the body. This technology reduces the need for implant removal surgery and minimizes the risk of adverse tissue reactions. ^{3 6 7 8 11}

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. The OSSIOfiber® Trimmable Fixation Nails used in this study will be considered on-label.

Eligibility Criteria

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

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)

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 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+

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

[Bone segment transport of the femur. Biomechanical value of an unreamed titanium intramedullary nail with reference to stiffness of external distraction systems]. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

The Fixion nail in the lower limb. Preliminary results. [2010]

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

Mechanical failure of unsupported Huckstep intramedullary nail in malignant bone tumor reconstruction. [2022]

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

Pathological Distal Tibial and Fibular Fracture in a Paediatric Patient: A Case Report. [2022]

6. 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]

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

The biointegration profile of fiber-reinforced plates following tibial implantation in sheep. [2023]

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

Carbon-Fiber-Reinforced Polymer Intramedullary Nails Perform Poorly in Long-Bone Surgery. [2022]

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

Carbon Fiber-Reinforced PEEK Versus Titanium Tibial Intramedullary Nailing: A Preliminary Analysis and Results. [2021]

10. France pubmed.ncbi.nlm.nih.gov

Fiber-reinforced fixation implant for proximal interphalangeal joint arthrodesis shows advanced implant bio-integration at 2-year follow-up. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Control of the micromovements of a composite-material nail design: A finite element analysis. [2016]