Corticosteroid Meniscectomy Randomized Trial

Launched by THE CLEVELAND CLINIC · Nov 17, 2020

Keywords

ClinConnect Summary

Symptomatic meniscal tear with pain and mechanical symptoms of catching and locking ,a phenotype of early OA, and often prompts patients who have failed physical therapy to elect APM to improve their symptoms. This arthroscopic surgery presents a unique opportunity to evaluate the intraarticular status of the joint including joint fluid biomarkers and synovial tissue for signs of inflammation in patients with mild to moderate OA. Since no post-op tissue repair is desired after APM, in contrast to other post-traumatic OA (PTOA) models such as anterior cruciate ligament reconstruction, the AP...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female age 40 and older
• • 2. Scheduled for APM with enrolling surgeon
• • 3. Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change
• • 4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• Exclusion Criteria:
• • 1. Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm
• • 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• • 3. Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide
• • 4. Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting)
• • 5. Injection with corticosteroid into affected knee in past 12 weeks
• • 6. Injection with platelet rich plasma into affected knee in past 12 weeks
• • 7. Injection with hyaluronic acid into affected knee in past 24 weeks
• • 8. Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure
• • 9. Bilateral surgery
• • 10. Unable to undergo MRI due to implanted medical device, aneurysm clamp, metal fragments in eye, etc.
• • 11. Absence of at least one area of grade 2 chondral change on diagnostic arthroscopy (patients without structural OA are excluded)