NCT01482624已完成不适用
Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain evaluation (ordinal 11-point Likert scale) on day 84.
研究概览
简要总结
The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.
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
- Single (Outcomes Assessor)
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
- •Male and female patients between 18 and 75 years of age.
- •Good general health condition.
- •Signed written informed consent.
- •Patients with necessity for arthroscopic meniscal surgery.
- •Ensured compliance of subject over the whole study period.
排除标准
- •Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
- •Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion.
- •Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study.
- •Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment.
- •Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
- •Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros).
- •List of concomitant medications not allowed which interfere with the functional assessments of this study.
- •Use of medication contraindicated for arthroscopic surgery.
- •Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint.
- •Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency.
- •Pregnant or lactating females.
- •Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index ≤ 1% (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,...) during the treatment period and the first 4 weeks of follow-up period.
- •Subjects having a high probability of non-compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient knowledge of local language).
- •Kellgren III-IV on study relevant side (confirmed by X-ray).
结局指标
主要结局
Pain evaluation (ordinal 11-point Likert scale) on day 84.
时间窗: Day 84
Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain).
次要结局
- Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy.(Day 0)
- Pain evaluation (ordinal 11-point Likert scale) on day 14.(Day 14)
- Pain evaluation (ordinal 11-point Likert scale) on day 42.(Day 42)
- Patient's and investigator's global evaluation of study-relevant knee complaints on day 14.(On Day 14)
- Patient's and investigator's global evaluation of study-relevant knee complaints on day 42.(On Day 42)
- Patient's and investigator's global evaluation of study-relevant knee complaints on day 84.(On Day 84)
- Range of Motion at baseline.(Baseline)
- Range of Motion on day of arthroscopy.(On Day 0)
- Range of Motion on day 14.(On Day 14)
- Range of Motion on day 42.(On Day 42)
- Range of Motion on day 84.(On Day 84)
- Frequency of test product-related Adverse Events(Up to Day 84)
- Walking ability on day 14.(On Day 14)
- Walking ability on day 42.(On Day 42)
- Walking ability on day of arthroscopy.(On Day 0)
- Walking ability on day 84.(On Day 84)
- Health-related quality of life questionnaire at baseline.(At baseline)
- Health-related quality of life questionnaire on day of arthroscopy.(On day 0)
- Health-related quality of life questionnaire on day 14.(On day 14)
- Health-related quality of life questionnaire on day 42.(On day 42)
- Health-related quality of life questionnaire on day 84.(On day 84)
- Joint Examination Parameters at baseline.(At baseline)
- Joint Examination Parameters on day of arthroscopy.(On Day 0)
- Joint Examination Parameters on day 14.(On Day 14)
- Joint Examination Parameters on day 42.(On Day 42)
- Joint Examination Parameters on day 84.(On Day 84)
- Pain evaluation (ordinal 11-point Likert scale) at baseline.(Baseline)
- Walking ability at baseline.(Baseline)
研究者
研究点 (2)
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