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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Subchondral Insufficiency Fracture
• Intervention / Treatment: Device: Ossiofiber® Trimmable Fixation Nail

• Study Type: Observational
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Current tobacco use or has quit within 3 months of study enrolment.
2. Substance abuse history.
3. Diabetes mellitus, HbA1c>8
4. High surgical risk due to pre-existing conditions.
5. Currently pregnant or has plans to become pregnant prior to surgery.
6. Active infection or history of chronic infection in study knee.
7. 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subchondral Insufficiency; Those who have subchondral insufficiency with tibial or femoral overload in the knee and are receiving the TFNs as standard of care.	Device: Ossiofiber® Trimmable Fixation Nail; 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.*

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)	Measures the knee health of individuals following surgery	6 months post-operatively
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form	IKDC measures: symptoms, athletic activity, and knee function.	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	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.	Up to 24 month post-operatively.
Degree of knee ligament healing	To see how the knee ligament is healing by MRI assessment.	6, 12, and 24 months
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.	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.	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.	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.	6 months post-operatively

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Seth L Sherman, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Fracture; Ossio; Kneebar; Subchondral insufficiency; Tibial overload; Femoral Overload
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 72105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No