The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis

NCT05806021 | Recruiting Phase 4

• 1 other identifier: 21.411
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Gonarthrosis

Keywords

corticosteroid injection; minimal dose; non-inferiority

Outcome Measures

Primary Outcomes (1)

• WOMAC Function

  Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), FUNCTION sub-score. The WOMAC is a 24-item questionnaire subdivided into three sections. It includes 5 items related to pain, 2 items related to stiffness, and 17 items related to physical function. Only function section will be used as the primary outcome measure. Responses to each of the 17 questions will be scored on graduated scales from 0 to 10 where 0 means no pain and 10 means the worst possible pain. Higher scores indicate greater symptom intensity. A total score out of a maximum of 68 points for function will be compiled and used for statistical analysis.

  1 month post-injection

Secondary Outcomes (3)

• WOMAC Total

  1, 2, 3 and 6 months post-injection

• VAS

  1, 2, 3 and 6 months post-injection

• LIKERT

  3 and 6 months post-injection

Study Arms (3)

Group A TA 40 mg

EXPERIMENTAL

intra-articular injection of 40 mg of triamcinolone acetonide, which is the standard dose used

Drug: Triamcinolone Acetonide

Group B TA 10 mg

ACTIVE COMPARATOR

intra-articular injection of 10 mg of triamcinolone acetonide

Drug: Triamcinolone Acetonide

Group C TA 5 mg

ACTIVE COMPARATOR

intra-articular injection of 5 mg of triamcinolone acetonide

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

Intra-articular injection. For each group, the total injected will be 3 ml. For syringes containing triamcinolone acetonide, the missing volume will be filled with 0.9% isotonic saline

Also known as: Kenalog

Group A TA 40 mg; Group B TA 10 mg; Group C TA 5 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier Universitaire de Montréal - Hôtel-Dieu

Montreal, Quebec, H2W 1T8, Canada

RECRUITING

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Related Links

• Outcome scale description

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dien Hung Luong, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dien Hung Luong, MD

CONTACT

5148908000; dh.luong79@gmail.com

Mathieu Boudier-Revéret, MD

CONTACT

5148908000; mathieu.boudier-reveret.med@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: January 15, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)