Corticosteroid Injection for Osteoarthritis (CoMeT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByMorgan H Jones, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The Cleveland Clinic

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 40 and over who are scheduled for arthroscopic partial meniscectomy (APM) due to osteoarthritis with evidence of grade 2 chondral change. Participants must be able to give informed consent and follow study requirements. Pregnant or nursing women, those planning pregnancy, recent recipients of knee injections, and individuals with severe OA or hypersensitivity to Zilretta or triamcinolone acetonide cannot participate.

Inclusion Criteria

I am scheduled for a procedure with the surgeon conducting this study.

My knee shows signs of moderate arthritis on a scan.

I am 40 years old or older.

Exclusion Criteria

I am scheduled for a procedure to repair or replace damaged cartilage or ligaments.

I am allergic to Zilretta or its components.

I am not pregnant, nursing, or planning to become pregnant, and I will not donate sperm during the study.

I am having surgery on both sides of my body.

I do not have moderate cartilage damage in at least one area.

Participant Groups

The trial is testing the effectiveness of an injectable product called Zilretta against a placebo in reducing synovitis-related symptoms after APM surgery. Synovitis is linked to increased symptoms and progression in osteoarthritis patients. The study aims to understand if targeting synovitis can improve outcomes post-surgery.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: corticosteroidExperimental Treatment1 Intervention

Triamcinolone extended release (32 mg) administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy. * Knee injury and Osteoarthritis Outcome Score (KOOS) pain at 6 and 12 months * T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months * Morphologic grading of cartilage using the MOAKS score at 3 and 12 months * 3D bone shape from MRI Osteoarthritis Knee Score (MOAKS) using statistical shape modeling at 3 and 12 months * Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months

Group II: PlaceboPlacebo Group1 Intervention

Normal saline of 5 mL administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy. * KOOS pain at 6 and 12 months * T1ρ and T2 imaging of cartilage and meniscus at 3 and 12 months * Morphologic grading of cartilage using the MOAKS score at 3 and 12 months * 3D bone shape from MRI using statistical shape modeling at 3 and 12 months * Improvement in blood, serum and urine inflammatory biomarker profiles at 3 and 12 months

Triamcinolone is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Kenalog for: