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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Canada
Centre Hospitalier Universitaire de Montréal - Hôtel-Dieu
RECRUITING
Montreal
Contact Information
Primary
Dien Hung Luong, MD
dh.luong79@gmail.com
5148908000
Backup
Mathieu Boudier-Revéret, MD
mathieu.boudier-reveret.med@ssss.gouv.qc.ca
5148908000
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2026-02
Participants
Target number of participants: 327
Treatments
Experimental: Group A TA 40 mg
intra-articular injection of 40 mg of triamcinolone acetonide, which is the standard dose used
Active_comparator: Group B TA 10 mg
intra-articular injection of 10 mg of triamcinolone acetonide
Active_comparator: Group C TA 5 mg
intra-articular injection of 5 mg of triamcinolone acetonide
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov