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Arthroscopic SurgeryNCT07468045

Functional Outcomes After Hyaluronic Acid Injections Following Arthroscopy

A study testing CG Synovia (Hyaluronic Acid 0.5%) in people with Arthroscopic Surgery, run by Daewoong Group Indonesia at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Arthroscopic Surgery
What is being tested?
CG Synovia (Hyaluronic Acid 0.5%)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesIndonesia
Study dates
9 Oct 2024to 7 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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).

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites
  • Siloam Hospitals Mampang

    Jakarta, 12760

  • MRCCC Siloam Hospitals Semanggi

    Jakarta, 12930

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Being tested
CG Synovia (Hyaluronic Acid 0.5%)
Keywords
Hyaluronic Acid, Knee Arthroscopy, Shoulder Arthroscopy, Arthroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07468045
Study groupRoleWhat they receive
Hyaluronic Acid 0,5%ExperimentalHyaluronic Acid 0,5%. 10ml pre-filled syringe for single use. Syringe equipped with Luer Lock which can be a safe needle attachment.
Receives: Device: CG Synovia (Hyaluronic Acid 0.5%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Evaluation

    Safety evaluation will be measured by monitoring the Adverse Events (AE)

    Measured: 4, 12 and 24 weeks

  2. 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

    Measured: 4 weeks

  3. 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 : %

    Measured: 4 weeks

  4. 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

    Measured: 4 weeks

  5. 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

    Measured: 4 weeks

  6. 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 : %

    Measured: 4 weeks

  7. 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 : %

    Measured: 4 weeks

  8. 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 : %

    Measured: 4 weeks

  9. 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 : %

    Measured: 4 weeks

  10. 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 : %

    Measured: 4 weeks

  11. 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

    Measured: 4 weeks

  12. 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

    Measured: 4 weeks

  13. 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

    Measured: 4 weeks

  14. 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

    Measured: 4 weeks

  15. 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

    Measured: 4 weeks

  16. 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

    Measured: 4 weeks

  17. 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

    Measured: 4 weeks

  18. 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

    Measured: 4 weeks

  19. 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

    Measured: Baseline and Weeks 4, 12, 24

  20. 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

    Measured: Baseline and Weeks 4, 12, 24

  21. 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

    Measured: Baseline and Weeks 4, 12, 24

  22. 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

    Measured: Baseline and Weeks 4, 12, 24

  23. 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

    Measured: Baseline and Weeks 4, 12, 24

  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).

    Measured: 4, 12 and 24 weeks

  25. 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.

    Measured: 4, 12 and 24 weeks

  26. 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.

    Measured: 4, 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start9 Oct 2024
  3. Primary completion7 Jul 2025
  4. Study completion7 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07468045
Sponsor's protocol ID
CG-SYN62001
Status last verified
Oct 2026
First submitted
25 Feb 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CG Synovia (Hyaluronic Acid 0.5%) in people with Arthroscopic Surgery, run by Daewoong Group Indonesia at 2 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Evaluation (time frame: 4, 12 and 24 weeks). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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