Status:
ENROLLING_BY_INVITATION
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
Lead Sponsor:
Stanford University
Conditions:
Subchondral Insufficiency Fracture
Eligibility:
All Genders
18+ years
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06138548
Start Date
October 31 2025
End Date
December 1 2027
Last Update
November 7 2025
Active Locations (2)
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1
Stanford University
Stanford, California, United States, 94305
2
Rush University
Chicago, Illinois, United States, 60612