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临床试验/NCT05806021
NCT05806021招募中4 期

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

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2024年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
327
试验地点
1
主要终点
WOMAC Function

研究概览

简要总结

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).

详细描述

Gonarthrosis is a very prevalent condition affecting especially people over the age of 60 years old. It is a major cause of pain and functional impairment in Canada. The prevalence and associated economic burden continue to increase.

Despite the prevalence of this condition, the management of symptomatic gonarthrosis remains a controversial subject. Multiple treatment alternatives are available, none of which has been proven to be superior to the others beyond any doubt. However, certain therapeutic modalities are better recognized and more frequently used, such as intra-articular corticosteroid injections. In 2022, an expert consensus review of the available literature concluded that the use of intra-articular corticosteroids is effective in the treatment of symptomatic gonarthrosis. This is also the conclusion of the most recent American College of Rheumatology (ACR) guideline, which "strongly recommends" the use of this type of injection in gonarthrosis .

Despite decades of use, there is insufficient evidence to recommend a specific type and dose of corticosteroid. The choice of cortisone type in the usual practice of physicians performing intra-articular knee infiltrations is therefore based on experience and the biochemical properties of the different cortisones. Those with larger particles due to esterification of the corticoid, such as triamcinolone acetonide (TA) and methylprednisolone acetate, are known to have a longer duration of action. They are therefore the two most frequently used in studies on the subject. The dose used is based on historical use and is not, to our knowledge, based on any fundamental evidence. This dose of TA injected into a joint is usually 40 mg. Some authors have shown us that it is not useful to inject higher doses than this into a knee because increasing the dose does not improve the outcome of the injection. However, there was no literature related to the minimally effective intra-articular TA dose in the knee, until recently. Indeed, Utamawatin et al. recently reported that 10mg of TA did not appear to be less effective than 40mg when injected into knees with primary osteoarthritis.

This minimally effective dose is important because side effects associated with cortisone use have been reported. The adverse effects of oral corticosteroids are better known and documented than intra-articular ones. By a mechanism that is only partially elucidated, intra-articular infiltrations can produce the same systemic effects as oral. Habib et al. reports that systemic side effects increase with the concentration and time of exposure to the substance. To our knowledge, the minimal dose of intra-articular corticosteroid to produce a systemic effect is not documented.

Systemic effects occur in multiple systems. They affect several metabolisms such as glucose, gastrointestinal, lipid, adipose tissue, bone, immune, cardiovascular, sex hormones and the hypothalamic-pituitary axis. The mood can also be affected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Group A TA 40 mg

Experimental

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

干预措施: Triamcinolone Acetonide (Drug)

Group B TA 10 mg

Active Comparator

intra-articular injection of 10 mg of triamcinolone acetonide

干预措施: Triamcinolone Acetonide (Drug)

Group C TA 5 mg

Active Comparator

intra-articular injection of 5 mg of triamcinolone acetonide

干预措施: Triamcinolone Acetonide (Drug)

结局指标

主要结局

WOMAC Function

时间窗: 1 month post-injection

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.

次要结局

  • 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)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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