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临床试验/CTRI/2026/01/100412
CTRI/2026/01/100412尚未招募4 期

A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Anterior Cruciate Ligament- ACL Reconstruction Procedure Using Adjustable Loop Suture Button and PEEK Interference Screw

Dr Kalpesh Maheshchandra Trivedi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月26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
80
试验地点
1

研究概览

简要总结

This will be a Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Anterior Cruciate Ligament ACL Reconstruction Procedure Using Adjustable Loop Suture Button and PEEK Interference Screw with a follow-up of one year.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Male or 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 and or 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 gretaer than or equal to 35 kg m2 3.Participants who had undergone previous surgery in the same or contralateral knee 4.Participants with a history of deep vein thrombosis (DVT) 5.Participants with arthritis of same or contralateral knee 6.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of thetrial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this clinical investigation plan 7.Pregnant and lactating female at the time of screening.

研究者

发起方
Dr Kalpesh Maheshchandra Trivedi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kalpesh Maheshchandra Trivedi

Aadya Arthroscopy and OrthoSports Hospital

研究点 (1)

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