Corticosteroid Meniscectomy Randomized Trial

• Status: Enrolling by invitation
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial meniscectomy (APM) was associated with worse symptoms while adjusting for confounding factors.Therefore, a better understanding of synovitis as a predictor of outcome after APM and as a target for treatment is needed to improve outcomes in this patient population.

Triamcinolone has been shown to decrease synovitis-associated outcomes in both animal and human studies after anterior cruciate ligament (ACL) injury. In a porcine model of ACL injury, treatment with triamcinolone resulted in decreased formation of synovitis-related collagen breakdown products as well as decreased cellularity of the synovium.And in a trial of triamcinolone injected after ACL injury, similar findings of decreased C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, was found in knees administered triamcinolone compared to placebo controls.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Arthritis Foundation
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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)