Corticosteroid Injection for Osteoarthritis

(CoMeT Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Must not be taking: Corticosteroids, Platelet rich plasma

Disqualifiers: Pregnancy, Severe OA, MRI restrictions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Morgan H Jones, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

You cannot have an MRI because you have a medical device implanted in your body, an aneurysm clamp, or metal fragments in your eye.

I am allergic to Zilretta or its components.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Triamcinolone extended release (32 mg) or placebo administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3, 6, and 12 months

12 months

3 visits (in-person)

Extension

Long-term monitoring of joint health and inflammation markers

Additional 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone
• Zilretta Injectable Product

Trial Overview 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.

How Is the Trial Designed?

Group I: corticosteroid Experimental Treatment 1 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: Placebo Placebo Group 1 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:

• Allergic rhinitis
• Asthma
• Atopic dermatitis
• Contact dermatitis
• Psoriasis
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis

Approved in Canada as Aristocort for:

• Allergic rhinitis
• Asthma
• Atopic dermatitis
• Contact dermatitis
• Psoriasis
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis

Approved in European Union as Triamcinolone acetonide for:

• Allergic rhinitis
• Asthma
• Atopic dermatitis
• Contact dermatitis
• Psoriasis
• Rheumatoid arthritis
• Osteoarthritis
• Bursitis
• Tendinitis

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Arthritis Foundation

Collaborator

Trials

36

Recruited

46,500+