Study of the Clinical and Biomechanical Effectiveness of Durolane SJ in Rhizarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Change From Baseline in Pain Measured by the VAS Scale
研究概览
简要总结
The main objective of the trial is to assess the clinical changes in terms of physical examination, VAS Scale and the Quick-DASH questionnaire, and the biomechanical parameters in terms of mobility of the TMC joint, the grip strength of the hand and lateral pinch strength in patients with rhizarthrosis after administration of viscosupplementation.
The secondary objectives of the trial will be to assess the safety of the treatment with viscosupplementation, and the correlation between the clinical and biomechanical changes at the end of the trial.
详细描述
This is a prospective, open, non-comparative study in 36 subjects with rhizarthrosis, comparing signs and symptoms before and after a single injection of DUROLANE SJ in the affected hand.
Subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment. This study is associated with a post marketing commitment with the European Notified Body, BSI, to confirm DUROLANE SJ's effectiveness in rhizarthrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes aged 18 to 75 years.
- •Diagnosis of Grade II-III rhizarthrosis in either hand, according to the criteria of Eaton and Littler.
- •TMC joint pain lasting longer than 6 months and baseline pain value greater than or equal to 4 on the VAS scale (0 to 10) and less than 4 in the contralateral hand joint if there is pain.
排除标准
- •Anticoagulant medication
- •Rheumatic disease involving the wrist, hand and fingers, such as rheumatoid arthritis or gout
- •Active rheumatoid arthritis
- •Previous surgery of the hand
- •Systemic infectious processes
- •Neoplastic disease
- •Subjects with contraindications to hyaluronic acid
- •Subjects with known hypersensitivity to hyaluronic acid or any of the components of the preparation under study
- •Previous hyaluronic acid injections in the hand
- •Subjects likely to miss the clinical follow-up visits
- •Taking of analgesics 24 hours before scheduled clinical assessments
- •Pregnant subjects
- •Any condition that in the opinion of the physician recommends exclusion of the subject
结局指标
主要结局
Change From Baseline in Pain Measured by the VAS Scale
时间窗: Baseline and 26 weeks
Visual Analogue Scale (VAS) pain in injected hand. The VAS scale ranges from 0 cm (least pain) to 10 cm (most pain). A Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
次要结局
- Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire(Baseline and 26 weeks)