CTRI/2025/01/078953尚未招募4 期
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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess functional outcomes of Knee in both the cohorts
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To assess functional outcomes of Knee in both the cohorts
时间窗: Screening/Baseline, 1 month, 3 months, 6 months and 12 months
次要结局
- 1. To evaluate knee pain in each cohort
研究者
Dr Lokesh A Veerappa
Manipal Hospital
研究点 (1)
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