CTRI/2023/04/051843进行中（未招募）4 期
A Randomized, Multi Center, Parallel, Open Label Study Assessing Clinical and Functional Outcomes After Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Interference Tibial Fixation with PEEK Interference Screw and PLDLA-BTCP Interference Screw
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- 1.To assess functional outcomes of Knee in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.
研究概览
简要总结
In current study we plan to evaluate and compare efficacy of both devices via change in IKDC, Modified Cincinnati Rating System Questionnaire, Lysholm knee score, Tegner activity scale scores, SANE and modified KOOS scale scores. Duration of surgery, ACL reconstruction failure assessment and time to recovery will also be done as a part of efficacy assessment. Efficacy and safety of both devices will also be compared. Clinical data collected through this study will be of great benefit to the research field and potentially will be beneficial to the society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/ female participants between ≥18 years and ≤ 45 years of age at the time of consent 2.Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery 3.Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
排除标准
- •1.Participants with lateral/medial collateral ligament injury or posterior cruciate ligament injury 2.Participants with BMI ≥35 kg/m2 3.Participants who had undergone previous surgery in the same or contralateral knee 4.Participants with HbA1c ˃ 9% (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C) 5.Participants who are smokers (smoking ˃20 cigarettes/day) 6.Participants with sensitivity to PEEK/PLDLA/B-TCP material 7.Participants with a history of deep vein thrombosis (DVT) 8.Participants with arthritis of same or contralateral knee 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 10.Pregnant and lactating female at the time of screening.
结局指标
主要结局
1.To assess functional outcomes of Knee in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.
时间窗: Screening, month 3, month 6,month 12, month 18 and month24
次要结局
- 1.To assess the clinical symptoms and activity level in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.(2.To assess the failure rate of ACL reconstruction in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.)
研究者
研究点 (5)
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