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.

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.

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).