Recruiting

Triamcinolone Acetonide

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05806021

Conditions

Primary Gonarthrosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Triamcinolone Acetonide

Study Details

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

Study ID

NCT05806021

Start date

Jan 15, 2024

Status verified date

Feb, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

327 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Triamcinolone Acetonide

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

Primary outcome measure

  • WOMAC Function [ Time Frame: 1 month post-injection ]

Central Contacts and Locations

Central contacts

Locations

Centre Hospitalier Universitaire de Montréal - Hôtel-Dieu

Recruiting

Montréal, Quebec, Canada, H2W 1T8

Contacts

Principal Investigator:

Dien Hung Luong, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 5, 2025

Last verified

Feb, 2025

Keywords

  • corticosteroid injection
  • minimal dose
  • non-inferiority

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-02-05.