Evaluation of Functional Outcomes in Patients Receiving Hyaluronic Acid Injections Following Arthroscopic Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Safety Evaluation
研究概览
简要总结
The goal of this study is to investigate the effect of hyaluronic acid injection on functional recovery and pain control in patients following knee or shoulder arthroscopy.
详细描述
The study consists of three main periods: screening, treatment, and follow-up. During the screening period, subjects will provide written informed consent and undergo screening assessments. Only those who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study.
During the treatment period, before completing the arthroscopy procedure, 10 mL of Hyaluronic Acid 0.5% (CG Synovia) will be injected into the joint cavity through the existing arthroscopy portal using a suitable needle attached to a Luer lock. The joint will then be moved through its full range of motion to ensure proper distribution of the product within the joint.
During the follow-up period, subjects will attend visits up to 24 weeks after treatment, specifically at 4 weeks (Visit 3), 12 weeks (Visit 4), and 24 weeks (Visit 5) for evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 18 to 60 years at the date of the written informed consent form.
- •Patient with surgery scheduled for arthroscopic procedure on knee or shoulder.
- •Those who could understand the provided information and were able to fill out the questionnaire.
- •Those who voluntarily decided to participate in the study and wrote the informed consent form.
排除标准
- •In the following cases that may affect test results
- •Patients with history and suspected of rheumatoid arthritis (RA).
- •Patients with osteoarthritis in the joint related to specific joint movement.
- •Those with a history of surgery in the related area of the join that affect join movement.
- •Patients with infection at the surgical site.
- •Patients with chronic diseases that may affect surgery, such as uncontrolled diabetes or uncontrolled high blood pressure.
- •Patients with complex regional pain syndrome.
- •If adverse reactions are expected during surgery in the following cases:
- •People taking blood coagulants or patients with diseases that require blood coagulants.
- •When there are restrictions on the use of anticoagulants or antithrombotic agents.
- •Those with confirmed severe liver dysfunction or decreased renal function.
- •Patients with other serious systemic diseases such as severe anemia.
- •Known HIV positive person receiving medication.
- •Patients are allergic to substances used in medical devices for the study (Hyaluronic Acid).
- •Pregnant, lactating, or women of childbearing potential who are unwilling to use contraception during the study.
- •Use of drugs or medical devices due to participation in other study
- •Other people deemed inappropriate to participate in the test by the investigator (including high probability of noncompliance).
研究组 & 干预措施
Hyaluronic Acid 0,5%
Hyaluronic Acid 0,5%. 10ml pre-filled syringe for single use. Syringe equipped with Luer Lock which can be a safe needle attachment.
干预措施: CG Synovia (Hyaluronic Acid 0.5%) (Device)
结局指标
主要结局
Safety Evaluation
时间窗: 4, 12 and 24 weeks
Safety evaluation will be measured by monitoring the Adverse Events (AE)
Change from baseline to 4 weeks in Haemoglobin concentration
时间窗: 4 weeks
Haemoglobin concentration count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : g/dL
Change from baseline to 4 weeks in Haematocrit
时间窗: 4 weeks
Haematocrit count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : %
Change from baseline to 4 weeks in White Blood Cell (WBC) count
时间窗: 4 weeks
White Blood Cell (WBC) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit 10³/µL
Change from baseline to 4 weeks in Platelet count
时间窗: 4 weeks
Platelet count count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : 10³/µL
Change from baseline to 4 weeks in Basophils (differential)
时间窗: 4 weeks
Basophils (differential) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : %
Change from baseline to 4 weeks in Eosinophils (differential)
时间窗: 4 weeks
Eosinophils (differential) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : %
Change from baseline to 4 weeks in Neutrophils (differential)
时间窗: 4 weeks
Neutrophils (differential) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : %
Change from baseline to 4 weeks in Lymphocytes (differential)
时间窗: 4 weeks
Lymphocytes (differential) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : %
Change from baseline to 4 weeks in Monocytes (differential)
时间窗: 4 weeks
Monocytes (differential) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : %
Change from baseline to 4 weeks in Random Blood Glucose
时间窗: 4 weeks
Random Blood Glucose count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : mg/dL
Change from baseline to 4 weeks in Urea
时间窗: 4 weeks
Urea count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : mg/dL
Change from baseline to 4 weeks in Creatinine
时间窗: 4 weeks
Creatinine count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : mg/dL
Change from baseline to 4 weeks in Aspartate aminotransferase (AST)
时间窗: 4 weeks
Aspartate aminotransferase (AST) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : U/L
Change from baseline to 4 weeks in Alanine aminotransferase (ALT)
时间窗: 4 weeks
Alanine aminotransferase (ALT) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : U/L
Change from baseline to 4 weeks in Prothrombin time (PT)
时间窗: 4 weeks
Prothrombin Time (PT) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : Seconds
Change from baseline to 4 weeks in Activated partial thromboplastin time (aPTT)
时间窗: 4 weeks
Activated Partial Thromboplastin Time (aPTT) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : Seconds
Change from baseline to 4 weeks in International normalised ratio (INR)
时间窗: 4 weeks
International Normalised Ratio (INR) count will be measured from venous blood samples analyzed by the site clinical laboratory using standard methods. Values will be summarized as change from baseline to 4 weeks. Unit : Ratio
Change from baseline to Weeks 4, 12, and 24 in active knee flexion range of motion
时间窗: Baseline and Weeks 4, 12, 24
Active knee flexion ROM (degrees) will be measured in the operated knee using a standard goniometer during clinical examination. Higher values indicate greater joint mobility. Unit : degrees
Change from baseline to Weeks 4, 12, and 24 in active shoulder abduction range of motion
时间窗: Baseline and Weeks 4, 12, 24
description : Active shoulder abduction ROM (degrees) will be measured in the operated shoulder using a standard goniometer during clinical examination. Higher values indicate greater joint mobility. Unit : degrees
Change from baseline to Weeks 4, 12, and 24 in active shoulder adduction range of motion
时间窗: Baseline and Weeks 4, 12, 24
Active shoulder adduction ROM (degrees) will be measured in the operated shoulder using a standard goniometer during clinical examination. Higher values indicate greater joint mobility. Unit : degrees
Change from baseline to Weeks 4, 12, and 24 in active shoulder flexion range of motion
时间窗: Baseline and Weeks 4, 12, 24
Active shoulder flexion ROM (degrees) will be measured in the operated shoulder using a standard goniometer during clinical examination. Higher values indicate greater joint mobility. Unit : degrees
Change from baseline to Weeks 4, 12, and 24 in active shoulder extension range of motion
时间窗: Baseline and Weeks 4, 12, 24
Active shoulder extension ROM (degrees) will be measured in the operated shoulder using a standard goniometer during clinical examination. Higher values indicate greater joint mobility. Unit : degrees
Exploratory Outcome
时间窗: 4, 12 and 24 weeks
Change from baseline in functional score related to shoulder joints using Shoulder and Pain Disability Index (SPADI) questionnaire which is a self-administered questionnaire that assesses shoulder pain and functional disability. It consists of two domains: a pain domain with five questions assessing the severity of pain (0 = no pain to 10 = worst pain imaginable), and a disability domain with eight questions evaluating the degree of difficulty in performing activities of daily living requiring upper-extremity use (0 = no difficulty to 10 = so difficult it requires help). The final score is calculated by summing the 5 pain items and 8 disability items, converting each subscale to a percentage of its maximum possible score, and averaging the two subscales to obtain a total score ranging from 0 to 100. higher scores indicating greater pain and disability (worse outcome).
次要结局
未报告次要终点