Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline
研究概览
简要总结
PMCF study to assess the effectiveness and safety of BENART in the treatment of symptomatic knee OA in a real-life clinical setting when used according to the instructions for use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •male or female aged between 18 and 99 years
- •diagnosis of symptomatic knee OA: Kellgren & Lawrence grade II/III
- •physician's recommendation to use BENART TM prior to recruitment
- •signed informed consent
排除标准
- •known allergy or hypersensitivity to any of the BENART TM components
- •infection or skin disease at or around the injection site
- •severe Inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...)
- •history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...)
- •evidence of lymphatic or venous stasis or serious blood disorders
- •known pregnancy or breast feeding
- •significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture)
- •individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)
结局指标
主要结局
Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline
时间窗: week 1, week 12, week 24, week 36
Knee injury and Osteoarthritis Outcome Score (KOOS) to assess pain, other symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec) and knee-related Quality of Life (QoL) on a 5-point Likert scale
Change of pain intensity compared to baseline (visual analogue scale, VAS)
时间窗: week 1, week 12, week 24, week 36
Evaluation of pain intensity by the patient on a 10 cm VAS-slider. 10 cm equals the worst pain.
Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10)
时间窗: week 1, week 12, week 24, week 36
The change of overall subjective symptom severity evaluation on a scale from 0 (very good condition) to 10 (very poor condition).
Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10)
时间窗: week 1, week 12, week 24, week 36
The change of clinical global Impression on a scale from 0 (very good condition) to 10 (very poor condition).
Responder rate according to OMERACT-OARSI criteria
时间窗: week 24
Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale)
时间窗: week 1, week 12, week 24, week 36
Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied)
Incidence of treatment-emergent Adverse Events
时间窗: Up to week 36
次要结局
未报告次要终点