Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 80 years of age
- •Minimum pain score of 2 according to modified Mayo Wrist Score
- •Patients in good general health/nutritional condition
- •Signed written informed consent
排除标准
- •Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
- •Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
- •Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
- •Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
- •Contraindication for the use of one of the investigational products or for the scheduled anesthesia
- •Concomitant or previous participation in a clinical trial within the last 3 months
- •Intraarticular treatment with a sodium hyaluronate-based product within the last 6 months
- •Intraarticular treatment by the use of corticoid containing substance within the last 3 months
- •Concomitant illness or injury influencing study evaluation
结局指标
主要结局
Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.
时间窗: Baseline and 3 months
Mayo wrist score evaluation consisting of 4 sections: * Maximal grip strength on injured side (compared to maximal strength of contralateral side, measured by 4-point scale, ranking from '0' for minimal to '30' for maximal strength) * Range of motion (measured by 4-point scale, ranking from '0' for minimal to '20' for maximal mobility) * Pain (measured by 4-point scale, ranking from '0' for maximal to '20' for minimal pain) * Function in daily activities (measured by 4-point scale, ranking from '0' for minimal to '30' for maximal function)
次要结局
- Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.(Measured during the 6-month duration of participation)
- Disabilities of the arm, shoulder, and hand (DASH) outcome measure(Measured during the 6-month duration of participation)
- Grip strength(Measured during the 6-month duration of participation)
- Visual analogue scale of pain (VAS; 100 mm)(Measured during the 6-month duration of participation)
- Clinical Global Impression (CGI)(Measured during the 6-month duration of participation)
- Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment.(Measured during the 6-month duration of participation)
- Number of subjects with Adverse Events as a measure of safety and tolerability(Measured during the 6-month duration of participation)