NCT05082480终止不适用
A Prospective, Double-Centre, Randomized, Evaluator/Subject-blinded, Control Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- The percentage of Total Active Motion (TAM) score for target finger.
研究概览
简要总结
To Evaluate the Effectiveness of the use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Trigger Finger Release Surgery
详细描述
The medical device is a bioabsorbable, extensible, crosslinked, 6% hyaluronic acid gel using fermentation sourced hyaluronic acid as a major component. This product could perfectly attach to the tissue surface, creating anti-adhesion layer which avoids post-surgical adhesion and is completely resorbed over time. This study is aimed to evaluate the effectiveness of the use of a novel crosslinking hyaluronan hydrogel on the prevention of the adhesion occurrence after trigger finger release surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to participate in this study and sign informed consent form
- •Age 20 to 65 years of male or female
- •The trigger finger, except thumb, classified as 3 to 4 points and plan to conduct trigger finger release surgery;
- •The trigger finger, except thumb, classified as 2 points with the symptom of flexion contracture and plan to conduct trigger finger release surgery;
- •Agree to comply with the follow-up schedule of this study
排除标准
- •Target finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, compression injury or other disease;
- •Other fingers in the same hand as the target finger have other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
- •Contralateral finger has other adhesion in tendon, joint, or proximal nerve, neuropathy, or compression injury;
- •The operation site was conducted tendon transplantation or any surgery in past 6 months;
- •Receiving orthopedic-related treatment which may affect the evaluation of the study;
- •The skin of the operation site with infection, deficiency, or needing skin transplantation;
- •With poorly controlled chronic diseases, such as diabetes mellitus;
- •Patient with autoimmune disease (such as rheumatoid arthritis), malignant tumors, coagulation diseases, heart diseases, mental diseases, etc., may cause patients to participate in the trial at higher risk;
- •Patient who has taken cortisol within the past 6 months, systemic corticosteroids within the past 2 months, immunosuppressive drugs within past 3 months, or non-steroidal anti-inflammatory drugs (NSAIDs) everyday within 1 week or NSAIDs within 8 hours occasionally. (subjects who have received inhaled/intranasal corticosteroids could be considered to include.);
- •With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or taking blood circulation promotion and blood stasis removement medications within the past 10 days;
- •With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study;
- •Pregnant, planning pregnancy or in breastfeeding females;
- •Other circumstances which judged to be unsuitable for participating in the study by the investigator.
结局指标
主要结局
The percentage of Total Active Motion (TAM) score for target finger.
时间窗: 30 days post-operation
The percentage of Total Active Motion (TAM) score for target finger at 30 days post-operation.
次要结局
- The percentage of TAM score of target finger.(baseline, 14, 60, 90, and 180 days post-operation)
- The grade of TAM score of target finger and contralateral finger.(baseline, 14, 30, 60, 90, and 180 days post-operation)
- The evaluation of tendon by sonography.(baseline, 14, 30, 60, 90, and 180 days post-operation)
- TAM score of target finger.(baseline, 14, 30, 60, 90, and 180 days post-operation)
- Subjects self-evaluating Visual Analogue Scale (VAS) in pain of target finger at baseline, 14, 30, 60, 90, and 180 days post-operation.(baseline, 14, 30, 60, 90, and 180 days post-operation)
- Subjects self-evaluating Visual Analogue Scale (VAS) in satisfaction(14, 30, 60, 90, and 180 days post-operation)
- Subjects self-evaluating Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-Dash).(baseline, 14, 30, 60, 90, and 180 days post-operation)
- The incidence, severity and correlation of adverse event (AE) and serious adverse event (SAE).(baseline, 14, 30, 60, 90, and 180 days post-operation)
研究者
研究点 (2)
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