Corticosteroid Meniscectomy Randomized Trial

Launched by THE CLEVELAND CLINIC · Nov 17, 2020

Keywords

ClinConnect Summary

This study tests whether giving an extended-release corticosteroid injection (Zilretta, tri amcinolone acetonide) at the end of knee arthroscopy surgery (arthroscopic partial meniscectomy, APM) can reduce knee pain and inflammation in people with mild-to-moderate osteoarthritis of the knee and a meniscal tear. It’s a randomized, double-blind trial, meaning people are assigned by chance to receive either the steroid injection or a placebo (saline), and neither the patient nor most study staff know which one was given. The main question is whether this approach improves knee pain 3 months after surgery, with several other outcomes studied over the year.

Who can join: adults aged 40 or older who are scheduled for APM and have evidence of structural knee OA (at least one area with grade 2 cartilage damage). Exclusions include pregnancy, very severe OA (grade IV), recent knee injections, certain MRI or surgical plans, and other factors that could affect safety or data quality. Participants will undergo questions about knee pain and function, plus research MRIs and biomarker tests (blood, urine, and joint fluid) at multiple time points up to 12 months. The trial is led by The Cleveland Clinic with sites in Boston and Cleveland, aiming to enroll about 150 people, with results around 2026.

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)