Efficacy of Therapy With Intra-articular Injections of PRP Compared With Therapy With Intra-articular Injections of HA, in Patients With Grade III or IV GONArthrosis: a Prospective Randomized Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional impact
研究概览
简要总结
Gonarthrosis is a chronic pathology affecting the knee joint and tissues. It is characterized by progressive degeneration of articular cartilage, bone and surrounding structures. Diagnosis is based on clinical, biological and radiological criteria.
When knee osteoarthritis becomes symptomatic, it leads to pain associated with stiffness and functional discomfort, impacting on patients' quality of life. Patients become sedentary and isolated, which has cardiovascular and psychological consequences, with a proven excess mortality rate.
To date, there are no curative treatments for gonarthrosis. Available treatments are generally aimed at relieving pain, improving joint function and slowing disease progression. Therapeutic approaches most often combine non-pharmacological treatments such as dietary measures, regular physical activity and therapeutic education, with pharmacological treatments: paracetamol, non-steroidal anti-inflammatory drugs, opioids, intra-articular injections of corticosteroids, hyaluronic acid (HA), Platelet Rich Plasma (PRP)... If these are ineffective, particularly in advanced stages (grades III-IV), then surgery for prosthesis is necessary. However, surgery is not an option for all patients, particularly those with co-morbidities, the elderly or those who refuse it.
The osteoarthritis section of the French rheumatology society has drawn up recommendations, with a view to positioning these treatments, standardizing practices and improving the management of gonarthrosis patients in France. These point out that further studies are needed to validate the efficacy of certain treatments, notably intra-articular PRP injections, which are nevertheless widely used in current practice and defended by a consensus of French experts published in 2021. Indeed, the results of several therapeutic trials and meta-analyses already published show that its efficacy is often superior to that of HA, particularly in terms of symptom improvement and over a longer duration. In order to make the case for their use to learned societies, literature data must be enriched, particularly with regard to advanced stages of gonarthrosis, i.e. stages III-IV, which are the most painful. The aim is to propose an effective treatment to relieve the symptoms of patients for whom surgery is not an option.
详细描述
In the PAGONA project, the investigators intend to use validated tools (WOMAC questionnaire, EVA scale, EQ-5D-5L quality of life questionnaire) to compare the effect of intra-articular injections of PRP with those of HA on the functional impact of the disease in patients with symptomatic knee osteoarthritis of moderate to severe stages (III-IV), by following these patients for 12 months after their last injection. The investigators plan to conduct a randomized, open-label study at the "Unité de Médecine et de Traumatologie du Sport" (UMTS) at Hôpital Sainte Musse in Toulon, where gonarthrosis treatment using intra-articular injections of PRP and HA is standard practice.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years ;
- •MRI confirmed grade III or IV unilateral gonarthrosis ;
- •Pain ≥ 3/10 on the visual analogue scale (VAS);
- •Patient with a BMI < 35
- •Patient capable of giving consent prior to participation in the study;
- •Affiliated or entitled under a social security scheme.
排除标准
- •Non-steroidal anti-inflammatory drugs* or corticosteroids** taken in the 7 days prior to inclusion;
- •Local injection of hyaluronic acid in the 2 months prior to inclusion;
- •Local injection of PRP within 1 year prior to inclusion;
- •Local injection of corticosteroids within 5 months prior to inclusion;
- •Current anticoagulant treatment that cannot be stopped during the hyaluronic acid or PRP injection protocol period;
- •Patient diagnosed with any type of cancer in the last 3 years;
- •Pregnant women, women in labour or breast-feeding women;
- •Patients under judicial protection (guardianship, curatorship, etc.) or safeguard of justice;
- •Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
- •Acetylsalicylic acid is allowed when it is prescribed as an antiplatelet agent at doses lower than or equal to 160 mg per day. It has, indeed, no anti-inflammatory effect at these doses.
- •Corticosteroids can be administered when they have a local action different from the one applied to the treated knee (cutaneous, instiled or inhaled routes).
研究组 & 干预措施
HA Injections
Group 1: HA injections (3 injections at 7-day intervals)
干预措施: intra-articular injection of HA (Procedure)
PRP Injections
Group 2: PRP injections (3 injections at 15-day intervals)
干预措施: intra-articular injection of PRP (Procedure)
结局指标
主要结局
Functional impact
时间窗: 3 months after the last intra-articular injection
The functional impact of the gonarthrosis will be assessed by the global WOMAC score, before injections and 3 months after the last injection, compared with the same score before treatment in each treatment group. The questionnaire consists of 24 questions divided into 3 categories: pain, physical function and stiffness. Each category offers a possible score range of 0 to 20 for pain, 0 to 68 for physical function, and 0 to 8 for stiffness. The sum of the scores for the three categories gives the total WOMAC score. The higher the score, the greater the functional impact of the gonarthrosis.
次要结局
- Functional impact(up to 12 months)
- Pain evaluation(up to 12 months)
- Failure rate(up to 12 months)
- Quality of life evaluation(up to 12 months)
- Adverse events(up to 12 months)