Enrolling by Invitation

NCT Number: NCT06138548

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.

Enrolling by Invitation

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Key information

Conditions

Subchondral Insufficiency Fracture Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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)

Treatment and study plan

Ossiofiber® Trimmable Fixation Nail

Device

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.*

Primary outcomes

Knee injury and Osteoarthritis Outcome Score (KOOS)

Time frame: 3 months post-operatively

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.
Knee injury and Osteoarthritis Outcome Scale Score (KOOS)

Time frame: 6 months post-operatively

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.

Secondary outcomes

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

Time frame: 6 months post-operatively

Measures the knee health of individuals following surgery
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form

Time frame: 6 months post-operatively

IKDC measures: symptoms, athletic activity, and knee function.
Veterans Rand-12 (VR-12) Health Survey Scale Score

Time frame: 6 months post-operatively

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
Numeric Pain Reported Scale Score

Time frame: 6 months post-operatively

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.
PROMIS Pain Interference Score

Time frame: 6 months post-operatively

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.
PROMIS Depression Score

Time frame: 6 months post-operatively

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.
PROMIS Physical Function Score

Time frame: 6 months post-operatively

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.
Incidence Assessments

Time frame: Up to 24 month post-operatively.

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

Time frame: 6, 12, and 24 months

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Nov 18, 2023
Registry last updated: Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Enrolling by Invitation