Subchondral Insufficiency Fracture
Conditions
Keywords
Ossio, Kneebar, Fracture, Subchondral insufficiency, Tibial overload, Femoral Overload
Brief 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). 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.
Interventions
DEVICEOssiofiber® 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.\*
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Physical Function Score | 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 | 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 | 6, 12, and 24 months | To see how the knee ligament is healing by MRI assessment. |
| Veterans Rand-12 (VR-12) Health Survey Scale Score | 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 | 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. |
| Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) | 6 months post-operatively | Measures the knee health of individuals following surgery |
| PROMIS Pain Interference Score | 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. |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form | 6 months post-operatively | IKDC measures: symptoms, athletic activity, and knee function. |
| PROMIS Depression Score | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSeth L Sherman, MD
Stanford University
Outcome results
None listed