Routine Application of Ostenil® Mini in Patients With Rhizarthrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
PMCF study to observe the routine application of Ostenil® Mini in the treatment of pain and restricted mobility in degenerative and traumatic changes of the CMC joint.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 years of age and in good general health condition
- •Signed informed consent
- •Existing Ostenil® Mini recommendation for the treatment of rhizarthrosis
排除标准
- •Known hypersensitivity to one of the Ostenil® Mini components
- •Known pregnancy or lactating females
- •Presence of coagulation disorder
- •Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
- •Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to Day 252 after the last injection
Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Measurement of Tip Pinch in kilograms with a Pinch Gauge
Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Measurement of Palmar Pinch in kilograms with a Pinch Gauge
Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale
Change of Pain Intensity compared to Baseline (VAS-slider)
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. (10 cm equal the worst pain)
Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale
Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse)
Change of Key Pinch Strength compared to Baseline (Pinch Gauge)
时间窗: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
Measurement of Key Pinch in kilograms with a Pinch Gauge
次要结局
未报告次要终点