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Subchondral Insufficiency FracturePhase 2NCT06423378

Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

A Phase 2 study testing OSSIOfiber® Trimmable Fixation Nails in people with Subchondral Insufficiency Fracture, run by Vanderbilt University Medical Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Subchondral Insufficiency Fracture
What is being tested?
OSSIOfiber® Trimmable Fixation Nails
Type of treatment
Medical device
How many people
10 participants
Where
1 siteUnited States
Study dates
5 Mar 2025to 5 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Agree to study participation and consent obtained.
  • Able to attend all postoperative clinical visits, undergo imaging procedures, and complete relevant questionnaires.
  • Subjects between the ages of 18 to 75 years.
  • Body Mass Index < 40.
  • Has knee pain in the study knee lasting at least 3 months and has had at least moderate pain recorded on a standard of care (SOC) preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS) and/or Numeric Pain Reported Scale (0-10) questionnaire. The study team may utilize these verbal pain scores collected during the clinic intake process for screening purposes. If the patient was not administered the verbal pain score, the patient will be consented, administered the pain survey, and withdrawn if moderate pain score was not recorded.
  • At least 3-months without steroid injection or any other non-surgical intervention administered to study knee.
Show all 10Show fewer
  • Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.
  • Uni-compartmental Kellgren-Lawrence grade 2-3 osteoarthritis in the study tibia or femur.
  • Bone Marrow Lesion (BML) confirmed on magnetic resonance imaging in the femur, tibia or both.
  • Cartilage lesion on the tibial or femoral condyle(s) of a grading ≤4 by either the International Cartilage Repair Society or Outerbridge classifications verified at the time of arthroscopy.

Who cannot join

  • Imaging evidence of the study knee that includes any of the following:
  • Kellgren-Lawrence grade 4 osteoarthritis.
  • Collapse of subchondral bone.
  • Avascular Necrosis (AVN).
  • Osteochondral defect overlying the BML
  • BML located at ACL or PCL insertions
Show all 23Show fewer
  • Clinical evidence of the study knee that includes any of the following:
  • History of rheumatoid arthritis, septic arthritis, reactive arthritis, gout or pseudogout, secondary arthropathy (e.g., hemochromatosis, hemophilia, or psoriasis).
  • Osteochondritis dissecans.
  • Frank ligamentous instability.
  • Neuromuscular deficiency or other that would limit the ability to do a functional assessment.
  • Bi-cortical nail implantation cannot be achieved, including where the required nail length is not yet available.
  • Current tobacco use or has quit within 3 months of study enrolment.
  • Substance abuse history.
  • Diabetes mellitus, HbA1c>8
  • High surgical risk due to pre-existing conditions.
  • Currently pregnant or has plans to become pregnant prior to surgery.
  • Active infection or history of chronic infection in study knee.
  • Will require concomitant procedures within study knee, including but not limited to ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation (Meniscal tears, including chronic, are acceptable if no repair is required)
  • Significant malalignment (varus or valgus) of the knee (>8°)
  • Use of augmentation or concomitant biologic therapy during surgery.
  • Contraindications to magnetic resonance imaging.
  • Any condition which in the view of the treating physician makes it inadvisable for the subject to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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.

Being tested
OSSIOfiber® Trimmable Fixation Nails

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSSIOfiber® Trimmable Fixation NailsDevice

    Subjects will be treated with cannulated nails before or after arthroscopic management of their concomitant pathology at the discretion of the investigator. Technique described below. Following nail placement, tissue layers will be closed in standard fashion.

    1. Preop MRI views used to estimate the proper depth \& location of nail placement on the femur and/or tibia
    2. Exposure is gained to medial tibia
    3. 1.4 mm K-Wire is placed through medial tibia parallel to the articular joint surface ~ 1 cm distal to the articular joint line
    4. A depth gauge is placed over K-Wire to determine required length of cannulated nail
    5. A 4.0 mm cannulated drill bit used over K-Wire to prepare the pilot hole
    6. Tamp is used to insert pre-trimmed 4.0 mm cannulated nail into the pilot hole and K-Wire is subsequently removed
    7. Intraop fluoroscopy can confirm adequate nail placement prior to removing K-wire
    8. Repeat steps for additional nails

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    The overall KOOS score combines pain and function domains. KOOS is out 100, where 0 equates to extreme pain and 100 equates to no pain.

    Measured: 3 months post-operatively

  2. Knee injury and Osteoarthritis Outcome Scale Score (KOOS)

    The overall KOOS score combines pain and function domains. KOOS is out 100, where 0 equates to extreme pain and 100 equates to no pain.

    Measured: 6 months post-operatively

Secondary outcomes (10)

  1. Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)

    Measures the knee health of individuals following surgery

    Measured: 6 months post-operatively

  2. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form

    IKDC measures: symptoms, athletic activity, and knee function.

    Measured: 6 months post-operatively

  3. Veterans Rand-12 (VR-12) Health Survey Scale Score

    VR-12 combines measures of general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, fatigue , social functioning, and mental health

    Measured: 6 months post-operatively

  4. Numeric Pain Reported Scale Score

    Measures a subject's perceived pain level. This score is usually on a scale of 0-10 with 0 equating to no pain and 10 equating to the worst pain imaginable.

    Measured: 6 months post-operatively

  5. PROMIS Pain Interference Score

    Measures what level pain hinders a patient's engagement in several activities including social, cognitive, physical, and recreational activities. There are 7 sub items and each are rated from a scale of 0-10 where 0 means it does not interfere and 10 means it completely interferes. These contribute to a final score ranging anywhere from 0-70.

    Measured: 6 months post-operatively

  6. PROMIS Depression Score

    Measures self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40. Higher scores indicate greater severity of depression.

    Measured: 6 months post-operatively

  7. PROMIS Physical Function Score

    Measures the level of physical function for patients with a wide variety of impairments that may limit the patient's physical capability. This score is on a scale from 0-100 with 0 equating to no physical function and 100 equating to optimal physical function.

    Measured: 6 months post-operatively

  8. Incidence Assessments

    Assessment of the incidence of re-operations, revision surgeries, or additional management of the study knee outside of postoperative rehabilitation.

    Measured: Up to 6 month post-operatively

  9. Degree of knee ligament healing

    To see how the knee ligament is healing by MRI assessment.

    Measured: Baseline and 6 months post-operatively

  10. Adverse Events

    Rate of postoperative adverse events and complications

    Measured: Up to 6 month post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start5 Mar 2025
  3. Primary completion5 Mar 2027 (estimated)
  4. Study completion5 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06423378
Sponsor's protocol ID
OSSIOfiber Kneebar
Status last verified
May 2026
First submitted
7 May 2024
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OSSIOfiber® Trimmable Fixation Nails in people with Subchondral Insufficiency Fracture, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: 3 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06423378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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