Using a special knee implant to treat knee pain from bone issues

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

This study is testing a new type of knee implant to see if it can help people aged 18 to 75 with knee pain from bone issues feel better and move more easily.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06423378 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency fractures in the knee. The study aims to improve patient-reported outcomes and imaging results by implanting these bio-integrative nails in a bi-cortical rafter formation within the tibia or femur. Participants will be monitored postoperatively to assess pain relief and functional improvement. The trial includes individuals aged 18 to 75 who have experienced knee pain for at least three months and are candidates for knee arthroscopy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with knee pain lasting at least three months and moderate pain levels.

Not a fit: Patients with a Body Mass Index over 40 or those who have received steroid injections or other non-surgical interventions in the past three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve knee function and reduce pain for patients suffering from subchondral insufficiency fractures.

How similar studies have performed: While this approach is innovative, similar studies using bio-integrative implants have shown promise in other orthopedic applications.

Eligibility criteria

Inclusion Criteria:

* Agree to study participation and consent obtained.
* Able to attend all postoperative clinical visits, undergo imaging procedures, and complete relevant questionnaires.
* Subjects between the ages of 18 to 75 years.
* Body Mass Index \< 40.
* Has knee pain in the study knee lasting at least 3 months and has had at least moderate pain recorded on a standard of care (SOC) preoperative Knee Injury and Osteoarthritis Outcome Score (KOOS) and/or Numeric Pain Reported Scale (0-10) questionnaire. The study team may utilize these verbal pain scores collected during the clinic intake process for screening purposes. If the patient was not administered the verbal pain score, the patient will be consented, administered the pain survey, and withdrawn if moderate pain score was not recorded.
* At least 3-months without steroid injection or any other non-surgical intervention administered to study knee.
* Candidate for knee arthroscopy due to meniscal tear, loose body, unstable articular cartilage or mechanical symptoms.
* Uni-compartmental Kellgren-Lawrence grade 2-3 osteoarthritis in the study tibia or femur.
* Bone Marrow Lesion (BML) confirmed on magnetic resonance imaging in the femur, tibia or both.
* Cartilage lesion on the tibial or femoral condyle(s) of a grading ≤4 by either the International Cartilage Repair Society or Outerbridge classifications verified at the time of arthroscopy.

Exclusion Criteria:

* Imaging evidence of the study knee that includes any of the following:

  1. Kellgren-Lawrence grade 4 osteoarthritis.
  2. Collapse of subchondral bone.
  3. Avascular Necrosis (AVN).
  4. Osteochondral defect overlying the BML
  5. BML located at ACL or PCL insertions
* Clinical evidence of the study knee that includes any of the following:

  1. History of rheumatoid arthritis, septic arthritis, reactive arthritis, gout or pseudogout, secondary arthropathy (e.g., hemochromatosis, hemophilia, or psoriasis).
  2. Osteochondritis dissecans.
  3. Frank ligamentous instability.
  4. Neuromuscular deficiency or other that would limit the ability to do a functional assessment.
* Bi-cortical nail implantation cannot be achieved, including where the required nail length is not yet available.
* 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)
* Significant malalignment (varus or valgus) of the knee (\>8°)
* Use of augmentation or concomitant biologic therapy during surgery.
* Contraindications to magnetic resonance imaging.
* Any condition which in the view of the treating physician makes it inadvisable for the subject to participate in the study.

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Lindsey Agnew, MS

Conditions Subchondral Insufficiency Fracture