The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis: a Non-inferiority Randomized Controlled Double-blind Study

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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 acetate (TA).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Symptomatic primary gonarthrosis of over 6 months duration (gonarthrosis according to the ACR criteria)

• Grade 1 to 3 Kellgren-Lawrence femorotibial osteoarthritis

• Knee pain provoked by activity over 4 and under 8 on 10 (VAS)

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