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临床试验/NCT04988698
NCT04988698已完成不适用

Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Hopital Nord Franche-Comte1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2021年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditions

研究概览

简要总结

Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. It consists of the intra-articular injection (IA) of hyaluronic acid (HA), to reduce knee pain by restoring normal joint homeostasis impaired by endogenous HA deficiency.

The IA administration of HA can be performed using 2 protocols: repeated weekly injections (3, sometimes 5 injections) and single injections. To date and there is no argument to favor either protocol. Regardless of the formula used, the safety of HA is excellent (RR of adverse reaction versus saline = 1.01, 95% CI 0.96-1.07, P = 0.6). The indication for viscosupplementation is the symptomatic treatment of mild to moderate knee osteoarthritis after failure and / or intolerance of analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs). In this indication, after HA injection the responder rate is in the order of 70% to 75% at 6 months and approximately 50% at 12 months. However, the predictors of the duration of effectiveness of SV are still unknown. The objective of the study is to research the factors influencing the duration of the effectiveness of SV, under real life conditions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • All adult outpatients, of both sexes, regardless of age, with a doctor-accepted diagnosis of knee OA and who have been treated with SV within the past 3 years

排除标准

  • Patients who have not been treated with SV in the past 3 years.
  • Patients who have been treated with VS for an indication other than osteoarthritis of the knee.
  • Patients in whom the assessment could not be performed reliably

结局指标

主要结局

Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditions

时间窗: At inclusion

Duration (in weeks) during which the patient was satisfied with the treatment

次要结局

  • Research for predictive factors will be carried out on the duration of satisfaction(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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