Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 42
- 主要终点
- Multimodal medical care osteoarthritis is non inferior (with a threshold of 15% for pain and function) to total knee arthroplasty in symptomatic radiographic knee osteoarthritis.
研究概览
简要总结
Knee is the most common site of osteoarthritis. Treatment of knee osteoarthritis starts with a full course of medical therapy, followed by surgery to replace the knee with a prosthesis if this strategy fails, or in advanced cases. However, the new recommendations of the French rheumatology society, which evaluate the various treatments and position them in the treatment plan, are not well known, and the definition of a complete treatment remains unclear. The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal (generally analgesics and corticosteroid or hyaluronic acid infiltrations). The goal of this study is to to select patients most likely to gain from surgery and to develop strategies that avoid the need for major surgery.
详细描述
Knee is the most common site of osteoarthritis. Treatment of knee osteoarthritis starts with a full course of medical therapy, followed by surgery to replace the knee with a prosthesis if this strategy fails, or in advanced cases.
However, the new recommendations of the French rheumatology society, which evaluate the various treatments and position them in the treatment plan, are not well known, and the definition of a complete treatment remains unclear. The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal (generally analgesics and corticosteroid or hyaluronic acid infiltrations).
Yet medical treatment has proved effective, suggesting that it could prevent a significant number of total knee arthroplasties. In addition, osteoarthritis of the knee is associated with various co-morbidities (diabetes, cardiovascular) that medical treatment can minimize (diet, physical activity).
The effectiveness of knee prostheses has been demonstrated, but up to 20% of patients continue to experience pain, and surgical procedures induce rare but serious events. Prostheses can also be revised, and are expensive.
This research is designed for patients suffering from femoro-tibial osteoarthritis who have been proposed total knee replacement by a surgeon, and aims to develop strategies to avoid the need for major surgery until the medical treatment arsenal adapted to the patient's situation has been tried.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years old
- •Femoro-tibial osteoarthritis Kellgren stage stage≥ 2 without laxity in extension;
- •A proposal of total knee replacement by a surgeon;
- •No corticosteroid joint injection within 3 months;
- •Visual analogic score pain (VAS) >40/100 but <90/100 or Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index function sub scale >40/100 at inclusion;
- •Wish to discuss medical care;
- •Able to consent and having signed a consent form.
排除标准
- •Contraindication or no indication to surgery or medical care (severe infection for example)
- •Inflammatory arthritis
- •Lack of social insurance
- •Symptomatic (VAS pain >40) contralateral knee or hip osteoarthritis (with or without replacement)
- •Pregnant or breastfeeding woman
- •Patient under court protection, guardianship, curatorship
- •Patient deprived of liberty
研究组 & 干预措施
Multimodal medical care arm
In the medical care arm, rheumatologists will list previous treatment, ongoing treatment and then order validated treatment (corticosteroid or hyaluronic acid joint injection if necessary, physical activity and weight loss in the event of obesity, other non-drug treatments (insole, orthosis) as well as other drug treatments (pain killers or non steroidal anti-inflammatory drugs) including validated tools (personalized program, filmed sessions and digital exercise media for regular practice at home, motivational e-mails). At least one modification will be discussed in each domain (physical activity, weight loss, insole, orthosis, assistive device when walking, joint injection, pills -pain killer acetaminophen and opioids- nonsteroidal anti inflammatory drugs -with classical rules - and others)
干预措施: Medical and non-medical treatments (Other)
Surgery arm
In the surgery arm, patients will have to plan, as initially suggested, their surgery (total knee arthroplasty)
干预措施: arthroplasty (Procedure)
结局指标
主要结局
Multimodal medical care osteoarthritis is non inferior (with a threshold of 15% for pain and function) to total knee arthroplasty in symptomatic radiographic knee osteoarthritis.
时间窗: 2 years
The outcome relates to two scales which constitute the composite principal endpoint; * Visual Analogic Score pain, VAS (scale 0-100) * Western Ontario and McMaster Universities function, WOMAC (scale 0-100) Success is defined by a VAS AND WOMAC scale ≤40/100 at 2 years Failure is defined by a VAS pain OR WOMAC scale \> 40/100 at 2 years.
次要结局
- To compare analgesic use by arm.(2 years)
- Study the proportion of delayed surgery in the medical group(2 years)
- Study the proportion of patients with severe events induced by surgery(2 years)
- Analyze the impact of physical activity on change of body mass by arm in the randomized population.(2 years)
- To compare the 0-2 years cost using the National Health Data System between the 2 groups.(0-2 years)
- To compare the 2-5 cost using the National Health Data System between the 2 groups.(2-5 years)