Actively Recruiting
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
Led by Vanderbilt University Medical Center · Updated on 2026-04-13
10
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The OSSIOfiber® Trimmable Fixation Nails used in this study will be considered on-label.
CONDITIONS
Official Title
Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate in the study and provide consent
- Able to attend all postoperative visits, undergo imaging, and complete questionnaires
- Age between 18 and 75 years
- Body Mass Index (BMI) less than 40
- Knee pain in the study knee lasting at least 3 months with at least moderate pain on standard pain scores
- At least 3 months without steroid injections or other non-surgical treatments to the study knee
- Candidate for knee arthroscopy due to meniscal tear, loose body, unstable cartilage, or mechanical symptoms
- Uni-compartmental Kellgren-Lawrence grade 2-3 osteoarthritis in the study tibia or femur
- Bone marrow lesion confirmed on MRI in the femur, tibia, or both
- Cartilage lesion graded 4 or less on International Cartilage Repair Society or Outerbridge scales verified at arthroscopy
You will not qualify if you...
- Kellgren-Lawrence grade 4 osteoarthritis on imaging
- Collapse of subchondral bone on imaging
- Avascular necrosis
- Osteochondral defect overlying bone marrow lesion
- Bone marrow lesion located at ACL or PCL insertions
- History of rheumatoid arthritis, septic arthritis, reactive arthritis, gout, pseudogout, or secondary arthropathy
- Osteochondritis dissecans
- Frank ligamentous instability
- Neuromuscular deficiency limiting functional assessment
- Inability to place bi-cortical nail due to nail length or anatomy
- Current tobacco use or quit within 3 months
- History of substance abuse
- Diabetes mellitus with HbA1c over 8
- High surgical risk due to pre-existing conditions
- Current pregnancy or planning pregnancy before surgery
- Active or chronic infection in study knee
- Need for other knee procedures like ligament reconstruction, tendon repair, meniscus repair, microfracture, osteotomy, or osteochondral transplantation
- Significant knee malalignment greater than 8 degrees
- Use of augmentation or biologic therapy during surgery
- Contraindications to MRI
- Any other condition that makes participation inadvisable according to the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
L
Lindsey Agnew, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here