Functional Outcomes After Hyaluronic Acid Injections Following Arthroscopy

Evaluation of Functional Outcomes in Patients Receiving Hyaluronic Acid Injections Following Arthroscopic Procedure

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.

Study Overview

• Status: Completed
• Conditions: Arthroscopic Surgery
• Intervention / Treatment: Device: CG Synovia (Hyaluronic Acid 0.5%)

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 12760
    • Siloam Hospitals Mampang
  • Jakarta, Indonesia, 12930
    • MRCCC Siloam Hospitals Semanggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CG 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 : %	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

Collaborators and Investigators

• Sponsor: Daewoong Group Indonesia
• Collaborators: CGBio Neoregen Indonesia
• Investigators: Principal Investigator: Prof. Dr. dr. Andri Marulitua Lubis Sp.OT(K), Siloam Hospitals Mampang

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 7, 2025

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Arthroscopy; Hyaluronic Acid; Knee Arthroscopy; Shoulder Arthroscopy
• Other Study ID Numbers: CG-SYN62001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No