Corticosteroid Injection for Osteoarthritis
(CoMeT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a corticosteroid injection called Triamcinolone to determine if it can reduce symptoms and slow the progression of osteoarthritis, a condition where knee cartilage wears down over time. The trial aims to better understand synovitis, the swelling of the joint lining that can worsen arthritis symptoms. Participants are divided into two groups: one receives the Triamcinolone injection, and the other receives a placebo (a harmless, inactive substance) for comparison. Suitable candidates for this trial are those scheduled for arthroscopic partial meniscectomy and diagnosed with structural osteoarthritis. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you've had certain injections in the affected knee recently, you may not be eligible to participate.
What is the safety track record for Triamcinolone and Zilretta Injectable Product?
Research has shown that triamcinolone, the treatment under study, is generally safe for people. Studies have found that triamcinolone injections, such as those used for knee pain, are usually well-tolerated. In past trials, patients experienced mild side effects, such as temporary pain at the injection site, with no serious safety issues reported.
The Zilretta injectable product, a long-lasting form of triamcinolone, also maintains a good safety record. Clinical studies indicate that most patients experienced only mild side effects, like swelling or soreness at the injection site, with serious problems being rare.
Both triamcinolone and the Zilretta product have been used in other treatments, supporting their safety record. While mild side effects can occur, serious risks remain uncommon.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for osteoarthritis, which often include oral medications like NSAIDs or injections of hyaluronic acid, the study drug Triamcinolone is unique because it is an extended-release corticosteroid injection. This extended-release formulation allows for a longer duration of action, potentially providing sustained pain relief and joint improvement over time. Researchers are excited about this treatment because it targets inflammation directly in the knee joint, which could lead to better management of osteoarthritis symptoms compared to conventional options. Additionally, the ability to assess improvements through advanced imaging and biomarker profiles offers a comprehensive way to gauge the treatment's effectiveness.
What evidence suggests that this treatment might be an effective treatment for osteoarthritis?
Research has shown that triamcinolone helps treat osteoarthritis by reducing pain and swelling. In this trial, participants may receive triamcinolone injections, which studies have shown result in significantly less pain compared to a placebo. The extended-release version, Zilretta, provided even longer-lasting pain relief, lasting up to 5-6 months. These findings suggest that triamcinolone, especially in its extended-release form, can significantly ease knee osteoarthritis symptoms.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Triamcinolone extended release (32 mg) or placebo administered as an intraarticular injection at the conclusion of arthroscopic partial meniscectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 3, 6, and 12 months
Extension
Long-term monitoring of joint health and inflammation markers
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?
2
Treatment groups
Experimental Treatment
Placebo Group
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
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:
- Allergic rhinitis
- Asthma
- Atopic dermatitis
- Contact dermatitis
- Psoriasis
- Rheumatoid arthritis
- Osteoarthritis
- Bursitis
- Tendinitis
- Allergic rhinitis
- Asthma
- Atopic dermatitis
- Contact dermatitis
- Psoriasis
- Rheumatoid arthritis
- Osteoarthritis
- Bursitis
- Tendinitis
- Allergic rhinitis
- Asthma
- Atopic dermatitis
- Contact dermatitis
- Psoriasis
- Rheumatoid arthritis
- Osteoarthritis
- Bursitis
- Tendinitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
Arthritis Foundation
Collaborator
Citations
The efficacy of intra-articular triamcinolone acetonide 10 ...
The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. Both 10 mg and 40 mg of TA significantly improved pain and ...
Improved Sleep Associated With Triamcinolone Acetonide ...
It excels at collecting extensive data on a range of treatments for knee OA, including clinical effectiveness and outcomes reported by patients themselves.
The Efficacy of Intra-articular Triamcinolone Acetonide 5mg ...
Indeed, Utamawatin et al. recently reported that 10mg of TA did not appear to be less effective than 40mg when injected into knees with primary osteoarthritis. ...
Comparison of 2 Dosages of Intraarticular Triamcinolone ...
Conclusion An 80-mg dose of triamcinolone acetonide had no additional benefit compared with 40 mg as treatment for knee arthritis.
Efficacy of Triamcinolone Acetonide Extended-Release in ...
Conclusion: TA-ER provided 5-6 months' pain relief that consistently exceeded saline-placebo and TAcs, suggesting that TA-ER injected intra-articularly into the ...
A randomized, phase IIa study to assess the systemic ...
This phase IIa study was designed to assess the safety and systemic triamcinolone acetonide exposure following injections of TA-ER or TAcs into each knee of ...
A Phase 3b, Open-label Study
Introduction: The aim of this work is to assess the safety and efficacy of repeat administration of triamcinolone acetonide extended-release (TA-ER) in patients ...
The effect of intra-articular extended-release triamcinolone ...
This open label clinical trial systematically evaluated the effects of intra-articular TA-ER on physical performance, self-reported function, and quality of ...
Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in ...
The primary outcome will be measured 72 hours after treatment by a sensor automatically uploading the data, thus we expect few dropouts are expected. Official ...
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mayoclinic.org
mayoclinic.org/drugs-supplements/triamcinolone-intra-articular-route/description/drg-20406593Triamcinolone (intra-articular route) - Side effects & uses
Triamcinolone injection is used to help relieve pain in the knees caused by osteoarthritis. ... Safety and efficacy have not been established.
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