Clinical trial: The Safety and Efficacy of Single IA-HA Injection in Patients With Knee Osteoarthritis: A Prospective Study (NCT04577521)

Eligibility criteria:
Inclusion Criteria:

          -  Patients Age should not be less than 18 years.

          -  Patients must be able to understand and follow the study procedures and must provide
             written informed consent.

          -  Radiologically Grade II or III osteoarthritis of knee according to the Kellgren and
             Lawrence classification.

          -  Mild to moderate documented diagnosis of knee osteoarthritis that fulfill the ACR
             (American College of Rheumatology) criteria.

          -  Patients with consistent symptoms (joint pain, crepitus, swelling, effusion alone or
             combination of these symptoms) of knee osteoarthritis for at least 3 months prior to
             screening. If bilateral knee pain is present, the more painful knee will be selected.

          -  Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs
             (NSAIDs) or other analgesic medication taken for any condition, including their knee
             pain. However patients will be allowed to use only acetaminophen or aspirin as a
             rescue pain medication during the study period. The patients must abstain from
             medication use 24 hours prior to any study visit.

        Exclusion Criteria:

          -  Patients with secondary osteoarthritis of the knee according to ACR criteria.

          -  Pregnant or lactating women, and women of childbearing potential not willing to use
             adequate contraception.

          -  Patients unable to stay in the study for 6 months, non- cooperating, not able to
             understand

          -  Patients having previously undergone surgery on target knee, including arthroscopy.

          -  Patients with neurological deficit in the lower extremities, with primary inflammatory
             joint disease, intra-articular tumours.

          -  Any severe systemic disease(s).

          -  Any significant osteoarthritis symptoms in other joints apart from the target knee
             which may require pharmacological treatment during the study.

          -  Patients who have received intra-articular hyaluronic acid within the previous 6 month
             and/or intra-articular steroids or articular lavage in the target knee within the
             previous 3 months prior to their inclusion in the study.

          -  Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the
             3 months prior to their inclusion in the study.

          -  History of allergy or hypersensitivity to hyaluronic acid.

          -  Participation in any clinical study in the last 3 months and any surgery scheduled in
             the next 8 months that can affect directly the result of the present study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment