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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 6, and 12 months
Awards & highlights

CoMeT Trial 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.Check my eligibility
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.See study design
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.

CoMeT Trial 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.

CoMeT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline and 3 months.
Secondary outcome measures
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

CoMeT 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

Find a Location

Who is running the clinical trial?

Arthritis FoundationOTHER
34 Previous Clinical Trials
46,001 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,926 Total Patients Enrolled
1 Trials studying Meniscus Tears
30 Patients Enrolled for Meniscus Tears
Morgan Jones, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Triamcinolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04641351 — Phase 4
Meniscus Tears Research Study Groups: corticosteroid, Placebo
Meniscus Tears Clinical Trial 2023: Triamcinolone Highlights & Side Effects. Trial Name: NCT04641351 — Phase 4
Triamcinolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641351 — Phase 4
Meniscus Tears Patient Testimony for trial: Trial Name: NCT04641351 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research actively recruiting volunteers?

"The trial, which was initially published on May 27th 2021 and revised lastly on June 30th 2022, is not presently open to enrollment. However, 519 other clinical studies are seeking participants at this moment in time."

Answered by AI

What is the highest number of participants this clinical trial can accommodate?

"Unfortunately, the recruitment phase of this medical trial has been completed; it first appeared on May 27th 2021 and was last edited June 30th 2022. However, there are 478 trials for synovitis and 41 for corticosteroid actively recruiting patients at present."

Answered by AI

What health conditions are treated with corticosteroid medications?

"Corticosteroid is a commonly used treatment for ulcerative colitis and other conditions like hand, brain, and dermatological disorders."

Answered by AI

What risks do corticosteroids pose to individuals utilizing them?

"With Phase 4 trials backing its safety, corticosteroid was rated a 3 on our risk scale."

Answered by AI

Has corticosteroid been employed in any other experiments of its kind?

"At the moment, there are 41 clinical trials focussing on corticosteroids with 8 being in Phase 3. Columbia, Missouri is a major centre for these studies; however, 75 sites across the globe host experiments related to this drug."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Ontario
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I had cortisone in the late spring. The 1st 2 weeks after it were no picnic but after that my knee was great! I am now back to pain and having difficulty to great difficulty doing the things I enjoy like riding my bicycle and hiking or simply going for a walk with my dog.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

What stage is it at? What results have they had so far?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Corticosteroid Meniscectomy Randomized Trial
Kurt Spindler, MD 2021. "Corticosteroid Meniscectomy Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04641351.
All > Osteoarthritis Knee > Knee Pain
~37 spots leftby Mar 2025
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