Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Injection Biolevox HA ONE: Injection Biolevox HA ONE with pH 6.8-7.4 contains high molecular weight sodium hyaluronate produced by bacterial fermentation, non-animal origin. lt is ste
Sponsors
Dr Lokesh A Veerappa
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants from 18 to 70 years of age at the time of consent. 2. Patient diagnosed with Knee OA as determined by the investigator using ACR Clinical Classification Criteria for Osteoarthritis of the knee fulfilling the following criteria Pain in the knee and 3 of the following: i. age more than 50 years of age ii. Less than 30 minutes of morning stiffness iii. Crepitus on active motion iv. Bony enlargement v. No palpable warmth of synovium 3. Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with BMI greater than or equal to 35 kg/m2 2. Participants who had undergone previous surgery in the same or contralateral knee 3. Participants with a history of deep vein thrombosis (DVT) 4. Patients with generalized OA 5. Pregnant and lactating female at the time of screening 6. Corticosteroid injection at treatment site within 1 month 7. Systemic use of corticosteroids within 2 weeks 8. Has received hyaluronic acid, PRP injection within 6 months 9. Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this clinical investigation plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess functional outcomes of Knee in both the cohortsTimepoint: Screening/Baseline, 1 month, 3 months, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate knee pain in each cohort 2. To assess quality of life in each cohort 3. To assess the safety in each cohort 4. To evaluate the requirement of an additional dose of investigational product/s or other therapy modalities Timepoint: 1. Screening/Baseline, 1 month, 3months, 6 months and 12 months. 2. Screening/ Baseline, 12 months 3. Screening/Baseline, 1 month, 3 months, 6 months and 12 months 4. 1 month, 3 months, 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr Lokesh A Veerappa
Manipal Hospital
Outcome results
None listed