NCT05806021 The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis
| NCT ID | NCT05806021 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Primary Gonarthrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 327 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 327 participants in total. It began in 2024-01-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Osteoarthritis of the knee is a common problem that is increasing in prevalence as the population ages. In a knee with osteoarthritis, there is variable damage to the articular cartilage and underlying bone that can cause varying degrees of pain. When pain is bothersome, osteoarthritis is treated to improve functional abilities. One of the most recognized and used treatments is intra-articular cortisone injection. Cortisone is a powerful anti-inflammatory drug that is used to reduce pain. Unfortunately, cortisone can have significant side effects, even when injected locally. The frequency and intensity of these side effects depend largely on the total dose injected. The main side effects include increased blood sugar levels, increased blood pressure and a temporary decrease in the secretion of the stress hormone, cortisol. In the long term, a decrease in articular cartilage thickness in the injected join and overall bone density reduction is also reported. Despite many years of routine use, the smallest effective dose of cortisone injected into the knee joint is unknown. The main objective of the study is to determine the impact on pain and function of different doses of cortisone injected into the knee. The cortisone chosen for this study is triamcinolone acetonide (TA).
Eligibility Criteria
Inclusion Criteria: * Symptomatic primary gonarthrosis of over 6 months duration (gonarthrosis according to the American College of Rheumatology criteria) * Grade 1 to 3 Kellgren-Lawrence femorotibial osteoarthritis * Knee pain provoked by activity over 4 and under 8 on 10 (Visual Analog Scale) Exclusion Criteria: * Bilateral symptomatic primary gonarthrosis * Grade 4 Kellgren-Lawrence femorotibial osteoarthritis * Isolated patellofemoral osteoarthritis * Intra-articular corticosteroid infiltration to the knee within the past 3 months or chronic use of per os corticosteroid * Intra-articular hyaluronic acid infiltration within the past 12 months. * Intra-articular infiltration of platelet-rich plasma within the past 12 months. * Disease affecting the study joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.). * Suspicion or presence of active local infectious process. * Presence or suspicion of local neoplasia or metastasis * Recent severe trauma to the knee (≤ 3 months) * Significant cognitive impairment or inadequate language proficiency not allowing adequate response to study questionnaires * Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection
Contact & Investigator
Dien Hung Luong, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT05806021 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Primary Gonarthrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05806021 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05806021 currently recruiting?
Yes, NCT05806021 is actively recruiting participants. Contact the research team at dh.luong79@gmail.com for enrollment information.
Where is the NCT05806021 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05806021 clinical trial?
NCT05806021 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Dien Hung Luong, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 327 participants.