CTRI/2025/01/078953
Not yet recruiting
Phase 4
Single Centre, Prospective, observational Study to Assess and Compare the Safety and Efficacy of Injection Biolevox HA ONE (Hyaluronic acid) and Injection Monoshot (Hyaluronic acid combined with platelet-rich plasma) in patients with Knee Osteoarthritis
Dr Lokesh A Veerappa1 site in 1 country60 target enrollmentStarted: September 8, 2025Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Dr Lokesh A Veerappa
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess functional outcomes of Knee in both the cohorts
Overview
Brief Summary
This is a Single Centre, Prospective, observational Study to Assess and Compare the Safety and Efficacy of Injection Hyaluronic acid and Injection Hyaluronic acid combined with platelet-rich plasma in patients with mild to moderate Knee Osteoarthritis
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female participants from 18 to 70 years of age at the time of consent.
- •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.
- •Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
Exclusion Criteria
- •Participants with BMI greater than or equal to 35 kg/m2
- •Participants who had undergone previous surgery in the same or contralateral knee
- •Participants with a history of deep vein thrombosis (DVT)
- •Patients with generalized OA
- •Corticosteroid injection at treatment site within 1 month
- •Systemic use of corticosteroids within 2 weeks
- •Has received hyaluronic acid, PRP injection within 6 months
- •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.
Outcomes
Primary Outcomes
To assess functional outcomes of Knee in both the cohorts
Time Frame: Screening/Baseline, 1 month, 3 months, 6 months and 12 months
Secondary Outcomes
- 1. To evaluate knee pain in each cohort
Investigators
Dr Lokesh A Veerappa
Manipal Hospital
Study Sites (1)
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