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.
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
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
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.
- Conditions
- Subchondral Insufficiency Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Subchondral Insufficiency | Those 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.
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
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)
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
Measures the knee health of individuals following surgery
Measured: 6 months post-operatively
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form
IKDC measures: symptoms, athletic activity, and knee function.
Measured: 6 months post-operatively
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
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
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
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
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
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.
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.
- First posted18 Nov 2023
- Study start31 Oct 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subchondral Insufficiency FractureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Sherman, Stanford University
- Investigators
- Seth L Sherman, MD, Principal investigator, Stanford University
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