CTRI/2025/01/079716
招募中
4 期
A Single Centre, Prospective, Randomized, Open Label Study Assessing Clinical and Functional Outcomes After Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Suspensory Tibial Fixation and Interference Tibial Fixation
Dr. Rudra Prasad M S1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月11日最近更新:
概览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Dr. Rudra Prasad M S
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess functional outcomes of Knee post-surgery within the groups and between the two groups.
概览
简要总结
This is a Single Centre, Prospective, Randomized, Open Label Study to Assess Clinical and Functional Outcomes After Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Suspensory Tibial Fixation and Interference Tibial Fixation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery
- •Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
排除标准
- •Participants with lateral/medial collateral ligament injury or posterior cruciate ligament injury
- •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)
- •Participants with arthritis of same or contralateral knee
- •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
- •Pregnant and lactating female at the time of screening.
结局指标
主要结局
To assess functional outcomes of Knee post-surgery within the groups and between the two groups.
时间窗: Screening/ Baseline, month 1.5, month 3, month 6, and month 12
次要结局
- 1. To assess the clinical symptoms and activity level between the two groups.(2. To assess the failure rate of ACL reconstruction between the two groups.)
研究者
Dr Rudra Prasad M S
SPARSH Super Specialty Hospital
研究点 (1)
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