NCT05603468进行中（未招募）4 期
Effect of Platelet-Rich Plasma vs Corticosteroid Injection in Distinct Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair: a Multicenter, Three-group, Randomized Controlled Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 387 人开始时间: 2022年12月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Oxford Shoulder Score (OSS)
研究概览
简要总结
Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy
详细描述
This clinical trial uses machine learning to match molecular and clinical features，so as to establish a "rapid recognition system of tendinopathy subtypes" and compares the clinical effects of corticosteroid，platelet rich plasma or placebo on different subtypes of tendinopathy.
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 (Participant)
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
- •Rotator cuff tears were diagnosis by magnetic resonance imaging or arthroscopy
- •Surgical intervention of rotator cuff tears was proposed.
- •Simple full-layer tear of supraspinatus tendon.
- •Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP
排除标准
- •Patients with rotator cuff injuries involving infraspinatus, subscapularis, and teres minor tendon injuries
- •Patients platelet concentration is lower than 100×109
- •Patients have other shoulder diseases, including osteoarthritis, cervical spondylosis, etc.patients have inflammatory diseases, including rheumatoid arthritis, fibromyalgia, rheumatic polymyalgia, etc.patients have received injection treatment within 3 months.
- •Patients have participated in clinical trials or are conducting other clinical trials within 3 months before screening.
- •Patients have severe primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that it is not suitable to be selected.
- •Patients have severe liver, kidney and hematological lesions, such as kidney function exceeding the upper limit of normal value and liver function exceeding 2 times the upper limit of normal value.
- •Patients have viral hepatitis, infectious diseases, severe abnormalities in blood coagulation and other diseases that the researchers consider unsuitable for surgery.
- •Women who are pregnant or lactating, or who plan to conceive during follow-up, those who are positive for human chorionic gonadotropin before sampling; menstrual women should wait for surgery after the end of menstruation.
- •Patients have severe neurological and mental disorders.
- •Patients suspect or do have a history of alcohol or drug abuse.
- •Patients have height body mass index (BMI) >
- •Patients have tendon disease caused by systemic immune or other diseases, and patients with diseases or symptoms that may affect pain or function scores.
- •Patients have coagulation disorders caused by any other acute or chronic disease.
- •MRI detection of contraindications. Include, but are not limited to: installation of pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, drug infusion devices implanted in the body, any electronic devices implanted in the body (nerve stimulators, bone growth stimulators), endovascular embolization steel rings, filters, ECG recording monitors, metal sutures, shrapnel or iron particles in the body, fixation of steel plates and nails after fracture surgery, Cochlear implant, middle ear graft, intraocular metal foreign body, etc. Claustrophobia, critically ill patients, etc.
- •Refer to the April 2008 edition of the Law of the people's Republic of China on the Protection of disabled Persons, patients belong to the subjects of legal disabled persons
- •Other situations in which the researchers judged that the subjects were not suitable to participate.
研究组 & 干预措施
Platelet Rich Plasma group
Experimental
patients rejected with platelet rich plasma
干预措施: platelet rich plasma (Drug)
Corticosteroid group
Active Comparator
patients rejected with corticosteroid
干预措施: Corticosteroid (Drug)
Normal saline group
Placebo Comparator
patients rejected with normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Oxford Shoulder Score (OSS)
时间窗: 6months after surgery
The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.
次要结局
- Fear-avoidance belief questionnaire(FABQ)(3 months, 6months, 1year, and 2years after surgery)
- SF-36(3 months, 6months, 1year, and 2years after surgery)
- Constant-Mulery score(CMS)(3 months, 6months, 1year, and 2years after surgery)
- muscle strength(3 months, 6months, 1year, and 2years after surgery)
- retear rate(3 months, 6months, 1year, and 2years after surgery)
- Signal to noise ratio of tendon in MRI(3 months, 6months, 1year, and 2years after surgery)
- Oxford Shoulder Score (OSS)(3 months, 1year, and 2years after surgery)
- Insomnia Severity Index(ISI)(3 months, 6months, 1year, and 2years after surgery)
- Hospital Anxiety and Depression Scale(HADS)(3 months, 6months, 1year, and 2years after surgery)
- range of motion(3 months, 6months, 1year, and 2years after surgery)
- Visual analogue scale(VAS)(3 months, 6months, 1year, and 2years after surgery)
- Acromiohumeral distance(3 months, 6months, 1year, and 2years after surgery)
研究者
研究点 (1)
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