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

Launched by STANFORD UNIVERSITY · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat knee pain caused by a condition called subchondral insufficiency fracture, which involves problems with the bone under the cartilage in the knee. Researchers want to see if using special implants called OSSIOfiber® Trimmable Fixation Nails can help improve both how patients feel and what doctors see on imaging tests. These nails are designed to help keep the bones in place while the knee heals, and they are used according to approved medical guidelines.

To join this study, participants should be between the ages of 65 and 74 and have experienced knee pain for at least three months. They also need to be candidates for a specific knee procedure called arthroscopy, usually due to issues like a torn meniscus or mechanical problems in the knee. However, individuals who smoke, have certain health conditions like diabetes, or are currently pregnant cannot participate. If someone decides to take part in this trial, they can expect to receive the new treatment and be monitored closely for their progress and recovery.

Gender

ALL

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)