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| Name | Class |
|---|---|
| CGBio Neoregen Indonesia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid 0,5% | Experimental | Hyaluronic Acid 0,5%. 10ml pre-filled syringe for single use. Syringe equipped with Luer Lock which can be a safe needle attachment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG Synovia (Hyaluronic Acid 0.5%) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | Safety evaluation will be measured by monitoring the Adverse Events (AE) | 4, 12 and 24 weeks |
| Change from baseline to 4 weeks in Haemoglobin concentration | 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 | 4 weeks |
| Change from baseline to 4 weeks in Haematocrit | 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 : % | 4 weeks |
| Change from baseline to 4 weeks in White Blood Cell (WBC) count | 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 | 4 weeks |
| Change from baseline to 4 weeks in Platelet count | 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 | 4 weeks |
| Change from baseline to 4 weeks in Basophils (differential) | 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 : % |
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Inclusion Criteria:
Exclusion Criteria:
In the following cases that may affect test results
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. dr. Andri Marulitua Lubis Sp.OT(K) | Siloam Hospitals Mampang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siloam Hospitals Mampang | Jakarta | 12760 | Indonesia | |||
| MRCCC Siloam Hospitals Semanggi |
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| 4 weeks |
| Change from baseline to 4 weeks in Eosinophils (differential) | 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 : % | 4 weeks |
| Change from baseline to 4 weeks in Neutrophils (differential) | 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 : % | 4 weeks |
| Change from baseline to 4 weeks in Lymphocytes (differential) | 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 : % | 4 weeks |
| Change from baseline to 4 weeks in Monocytes (differential) | 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 : % | 4 weeks |
| Change from baseline to 4 weeks in Random Blood Glucose | 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 | 4 weeks |
| Change from baseline to 4 weeks in Urea | 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 | 4 weeks |
| Change from baseline to 4 weeks in Creatinine | 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 | 4 weeks |
| Change from baseline to 4 weeks in Aspartate aminotransferase (AST) | 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 | 4 weeks |
| Change from baseline to 4 weeks in Alanine aminotransferase (ALT) | 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 | 4 weeks |
| Change from baseline to 4 weeks in Prothrombin time (PT) | 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 | 4 weeks |
| Change from baseline to 4 weeks in Activated partial thromboplastin time (aPTT) | 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 | 4 weeks |
| Change from baseline to 4 weeks in International normalised ratio (INR) | 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 | 4 weeks |
| Change from baseline to Weeks 4, 12, and 24 in active knee flexion range of motion | 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 | Baseline and Weeks 4, 12, 24 |
| Change from baseline to Weeks 4, 12, and 24 in active shoulder abduction range of motion | 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 | Baseline and Weeks 4, 12, 24 |
| Change from baseline to Weeks 4, 12, and 24 in active shoulder adduction range of motion | 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 | Baseline and Weeks 4, 12, 24 |
| Change from baseline to Weeks 4, 12, and 24 in active shoulder flexion range of motion | 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 | Baseline and Weeks 4, 12, 24 |
| Change from baseline to Weeks 4, 12, and 24 in active shoulder extension range of motion | 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 | Baseline and Weeks 4, 12, 24 |
| Exploratory Outcome | 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). | 4, 12 and 24 weeks |
| Exploratory Outcome | Change from baseline in functional score related to knee joints using The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire which is a patient-reported questionnaire used to assess pain, stiffness, and physical function in individuals with knee osteoarthritis. The questionnaire consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a scale from 0 to 4, and the total score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and functional limitation. | 4, 12 and 24 weeks |
| Exploratory Outcome | Pain score will be assessed based on the change from baseline in the Numeric Rating Scale (NRS) from 1-10 where 0 indicates no pain and 10 indicates the worst pain imaginable. | 4, 12 and 24 weeks |
| Jakarta |
| 12930 |
| Indonesia |