Clinical trial NCT06138548: Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
Official title: Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subchondral Insufficiency Fracture
Keywords: Ossio
Kneebar
Fracture
Subchondral insufficiency
Tibial overload
Femoral Overload
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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). 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 3 months post-operatively
measure: Knee injury and Osteoarthritis Outcome Scale Score (KOOS)
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
timeFrame: 6 months post-operatively
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form
timeFrame: 6 months post-operatively
measure: Veterans Rand-12 (VR-12) Health Survey Scale Score
timeFrame: 6 months post-operatively
measure: Numeric Pain Reported Scale Score
timeFrame: 6 months post-operatively
measure: PROMIS Pain Interference Score
timeFrame: 6 months post-operatively
measure: PROMIS Depression Score
timeFrame: 6 months post-operatively
measure: PROMIS Physical Function Score
timeFrame: 6 months post-operatively
measure: Incidence Assessments
timeFrame: Up to 24 month post-operatively.
measure: Degree of knee ligament healing
timeFrame: 6, 12, and 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Seth L Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: