CTRI/2023/04/051751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 Suspensory Tibial Fixation with Open and Closed Peek Button
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
- 4
- 主要终点
- 1. To assess functional outcomes of Knee in each cohort of Peek button-open and Peek button-closed.
研究概览
简要总结
In current study we plan to evaluate andcompare efficacy of both devices via change in IKDC, Modified Cincinnati RatingSystem Questionnaire, Lysholm knee score, Tegner activity scale scores, SANEand modified KOOS scale scores. Duration of surgery, ACL reconstruction failureassessment and time to recovery will also be done as a part of efficacyassessment. Efficacy and safety of both devices will also be compared. Clinicaldata collected through this study will be of great benefit to the researchfield 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
- •Male/ female participants between ≥18 years and ≤ 45 years of age at the time of consent
- •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 ≥35 kg/m2
- •Participants who had undergone previous surgery in the same or contralateral knee
- •Participants with HbA1c ˃ 9% (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C)
- •Participants who are smokers (smoking ˃20 cigarettes/day)
- •Participants with sensitivity to PEEK material
- •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
1. To assess functional outcomes of Knee in each cohort of Peek button-open and Peek button-closed.
时间窗: Screening, month 3, month 6, month 12, month 18 and month 24
次要结局
- 1. To assess the clinical symptoms and activity level in each cohort of Peek button-open and Peek button-closed from baseline (pre-surgery).(2. To assess the failure rate of ACL reconstruction in each cohort of Peek button-open and Peek button-closed.)
研究者
研究点 (4)
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