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

Study Overview
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Brief Summary
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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. This use is not considered off-label because we are using the TFNs in the way they are intended to be used via FDA approval.

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

Conditions
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Subchondral Insufficiency Fracture

Intervention / Treatment
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* Device: Ossiofiber® Trimmable Fixation Nail


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subchondral Insufficiency<br>Those who have subchondral insufficiency with tibial or femoral overload in the knee. | Device: Ossiofiber® Trimmable Fixation Nail<br>* 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.*<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ossio, Kneebar, Fracture, Subchondral insufficiency, Tibial overload, Femoral Overload