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Subchondral Insufficiency FractureNCT06138548

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

An observational study of Subchondral Insufficiency Fracture, run by Stanford University at 2 sites 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 years and older
Conditions the study is for
Subchondral Insufficiency Fracture
What is being tested?
Ossiofiber® Trimmable Fixation Nail
Type of treatment
Medical device
How many people
10 participants
Where
2 sitesUnited States
Study dates
31 Oct 2025to Dec 2027
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Those who have subchondral insufficiency of the knee with tibial or femoral overload.

Who may be able to join

  • Has had knee pain in study knee lasting at least 3 months
  • Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.

Who cannot join

  • 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)

Trial locations and contacts

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

United States2 sites

  • Rush University

    Chicago, Illinois, 60612

  • Stanford University

    Stanford, California, 94305

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). The 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 the TFNs are being used in the way they are intended to be used via FDA approval.

Being tested
Ossiofiber® Trimmable Fixation Nail
Keywords
Ossio, Kneebar, Fracture, Subchondral insufficiency, Tibial overload, Femoral Overload
Medical subject headings
Fractures, Bone

What participants receive

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

  • Ossiofiber® Trimmable Fixation NailDevice

    OSSIOfiber® Trimmable Fixation Nails are equally strong in the initial stability and fixation strength - and superior in rotational resistance to traditional metal cannulated headless compression screws.*

Study groups in NCT06138548
Study groupRoleWhat they receive
Subchondral InsufficiencyThose who have subchondral insufficiency with tibial or femoral overload in the knee and are receiving the TFNs as standard of care.
Receives: Device: Ossiofiber® Trimmable Fixation Nail

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 (9)

  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 24 month post-operatively.

  9. Degree of knee ligament healing

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

    Measured: 6, 12, and 24 months

Timeline

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

  1. First posted18 Nov 2023
  2. Study start31 Oct 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138548
Sponsor's protocol ID
72105
Status last verified
Aug 2026
First submitted
14 Nov 2023
Last updated
17 Aug 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?

An observational study of Subchondral Insufficiency Fracture, run by Stanford University at 2 sites 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 2 inclusion and 7 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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 NCT06138548.

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 17 Aug 2026.

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