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Completed

NCT Number: NCT07468045

Functional Outcomes After Hyaluronic Acid Injections Following Arthroscopy

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.

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Key information

Conditions

Arthroscopic Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MRCCC Siloam Hospitals Semanggi, Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Safety Evaluation

    Time frame: 4, 12 and 24 weeks

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

  2. Change from baseline to 4 weeks in Haemoglobin concentration

    Time frame: 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

  3. Change from baseline to 4 weeks in Haematocrit

    Time frame: 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 : %

  4. Change from baseline to 4 weeks in White Blood Cell (WBC) count

    Time frame: 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

  5. Change from baseline to 4 weeks in Platelet count

    Time frame: 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

  6. Change from baseline to 4 weeks in Basophils (differential)

    Time frame: 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 : %

  7. Change from baseline to 4 weeks in Eosinophils (differential)

    Time frame: 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 : %

  8. Change from baseline to 4 weeks in Neutrophils (differential)

    Time frame: 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 : %

  9. Change from baseline to 4 weeks in Lymphocytes (differential)

    Time frame: 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 : %

  10. Change from baseline to 4 weeks in Monocytes (differential)

    Time frame: 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 : %

  11. Change from baseline to 4 weeks in Random Blood Glucose

    Time frame: 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

  12. Change from baseline to 4 weeks in Urea

    Time frame: 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

  13. Change from baseline to 4 weeks in Creatinine

    Time frame: 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

  14. Change from baseline to 4 weeks in Aspartate aminotransferase (AST)

    Time frame: 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

  15. Change from baseline to 4 weeks in Alanine aminotransferase (ALT)

    Time frame: 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

  16. Change from baseline to 4 weeks in Prothrombin time (PT)

    Time frame: 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

  17. Change from baseline to 4 weeks in Activated partial thromboplastin time (aPTT)

    Time frame: 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

  18. Change from baseline to 4 weeks in International normalised ratio (INR)

    Time frame: 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

  19. Change from baseline to Weeks 4, 12, and 24 in active knee flexion range of motion

    Time frame: 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

  20. Change from baseline to Weeks 4, 12, and 24 in active shoulder abduction range of motion

    Time frame: 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

  21. Change from baseline to Weeks 4, 12, and 24 in active shoulder adduction range of motion

    Time frame: 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

  22. Change from baseline to Weeks 4, 12, and 24 in active shoulder flexion range of motion

    Time frame: 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

  23. Change from baseline to Weeks 4, 12, and 24 in active shoulder extension range of motion

    Time frame: 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

  24. Exploratory Outcome

    Time frame: 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).

  25. Exploratory Outcome

    Time frame: 4, 12 and 24 weeks

    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.

  26. Exploratory Outcome

    Time frame: 4, 12 and 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Daewoong Group Indonesia

Industry

Collaborators

  • CGBio Neoregen Indonesia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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