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Corticosteroid

Corticosteroid Injection for Osteoarthritis (CoMeT Trial)

Phase 4

Waitlist Available

Led By Morgan Jones, MD, MPH

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for APM with enrolling surgeon

Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change

Must not have

Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure

Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 6, and 12 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial found that a single intra-articular injection of triamcinolone acetonide was associated with decreased cartilage breakdown products in the early stages of OA, specifically in patients with higher degrees of synovitis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased blood sugar levels (especially important for diabetics), immune system suppression leading to higher infection risk, thinning skin around the injection area, adrenal gland problems, cataracts or glaucoma with repeated injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My knee shows signs of moderate arthritis on a scan.

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am allergic to Zilretta or its components.

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

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I am having surgery on both sides of my body.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.

Secondary study objectives

Change in Inflammatory biomarkers in circulation from baseline, 3 and 12 months.

Change in Inflammatory biomarkers of the knee joint from baseline, 3, and 12 months.

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline, 6 and 12 months.

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

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

0 / 8Eligibility criteria met