Health Condition 1: null- Patients with Knee Osteoarthritis (OA)
Conditions
Interventions
Intervention1: Biovisc Ortho: Content: Hyaluronic acid
Dose: 20mg/2ml
Route of Administration: Intra-Articular
Control Intervention1: NA: NA
Sponsors
VMMC and Safdarjung Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, >= 40 years and 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale [Time Frame: Baseline, at end of 3rd Injection cycle, 5th Injection cycle, at 3 Months and 6 Months follow-up ]Timepoint: At 3 Months and 6 Months follow-up ] | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Overall improvement in KOOS Score â?¢ Symptoms â?¢ Stiffness â?¢ Function: Daily Living â?¢ Function: Sports and recreational activity â?¢ Quality of Life â?¢ Overall safety of Biovisc Ortho (HA) using Treatment Emergent Adverse EventsTimepoint: At 3 Months and 6 Months follow-up | — |
Countries
India
Contacts
Public ContactDr Ajay Gupta
VMMC and Safdarjung Hospital
Outcome results
None listed