Arthroscopic Surgery
Conditions
Keywords
Hyaluronic Acid, Knee Arthroscopy, Shoulder Arthroscopy, Arthroscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICECG Synovia (Hyaluronic Acid 0.5%)
After arthroscopic procedure, attach a suitable needle to the Luer Lock and inject 10ml of CG Synovia into the joint cavity through a portal already placed in the joint for arthroscopy. Move the joint through full range of motion to allow CG Synovia to distribute throughout the joint, synovium, and joint surfaces.
Sponsors
Daewoong Group Indonesia
CGBio Neoregen Indonesia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female adults aged 18 to 60 years at the date of the written informed consent form. 2. Patient with surgery scheduled for arthroscopic procedure on knee or shoulder. 3. Those who could understand the provided information and were able to fill out the questionnaire. 4. Those who voluntarily decided to participate in the study and wrote the informed consent form.
Exclusion criteria
1. In the following cases that may affect test results 1. Patients with history and suspected of rheumatoid arthritis (RA). 2. Patients with osteoarthritis in the joint related to specific joint movement. 3. Those with a history of surgery in the related area of the join that affect join movement. 4. Patients with infection at the surgical site. 2. Patients with chronic diseases that may affect surgery, such as uncontrolled diabetes or uncontrolled high blood pressure. 3. Patients with complex regional pain syndrome. 4. If adverse reactions are expected during surgery in the following cases: 1. People taking blood coagulants or patients with diseases that require blood coagulants. 2. When there are restrictions on the use of anticoagulants or antithrombotic agents. 3. Those with confirmed severe liver dysfunction or decreased renal function. 4. Patients with other serious systemic diseases such as severe anemia. 5. Known HIV positive person receiving medication. 5. Patients are allergic to substances used in medical devices for the study (Hyaluronic Acid). 6. Pregnant, lactating, or women of childbearing potential who are unwilling to use contraception during the study. 7. Use of drugs or medical devices due to participation in other study 8. Other people deemed inappropriate to participate in the test by the investigator (including high probability of noncompliance).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to 4 weeks in Neutrophils (differential) | 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 : % |
| Safety Evaluation | 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 | 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 | 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 | 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 | 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) | 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) | 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 Lymphocytes (differential) | 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) | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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). |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORProf. Dr. dr. Andri Marulitua Lubis Sp.OT(K)
Siloam Hospitals Mampang
Outcome results
None listed