Prospective Single Centre Open label investigator initiated clinical study to evaluate the Efficacy and Safety of Intra-Articular Hyaluronic Acid (HA)(Biovisc Ortho) in Patients with Knee Osteoarthritis (OA)

VMMC and Safdarjung Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients of either gender, >= 40 years and <= 75 years of age.
•2. Documented diagnosis of primary osteoarthritis of knee with Unilateral or Bilateral involvement as per the ACR (American College of Rheumatology) criteria.
•3. Radiologically Grade II and III osteoarthritis of knee according to the Kellgren and Lawrence classification.
•4. Subject 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.
•5. Minimum 3 months of unsuccessful non-surgical treatment, including (but not limited to) acetaminophen, anti-inflammatory medication, cortisone injection, physical therapy and bracing.
•6. Subject 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.
•7. Subject must be able to understand and follow the study procedures and must provide written informed consent.

•1. Subject having previously undergone surgery on target knee, including arthroscopy.
•2. Subject with neurological deficit in the lower extremities.
•3. Subject with Primary inflammatory joint disease, intra-articular tumours.
•4. Subject with comorbidities that impairing the ability to participate in functional daily activities
•5. Any significant osteoarthritis symptoms in other joints apart from knees which may require pharmacological treatment during the study.
•6. Subject 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.
•7. Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
•8. History of allergy or hypersensitivity to hyaluronic acid.
•9. 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.

发起方

VMMC and Safdarjung Hospital