A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Procedure using Fixed Loop UHMWPE Suture Titanium Button and Titanium Interference Screw.

Healthium Medtech Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•1.Male and female subjects between 18 to 45 years of age.
•2.Subjects with ACL injury with or without associated meniscus injuries requiring primary ACL reconstruction surgery.
•3.Subject willing to give written informed consent to participate in the study.

•1.Subjects with Posterior Cruciate Ligament injury, and/or Collateral ligament injury.
•2.Subjects with known hypersensitivity to titanium and/or UHMWPE suture.
•3.Subjects with BMI =35 kg/m2
•4.Subjects with a history of previous knee surgery
•5.Subjects with the insufficient quantity or skeletally immature bone.
•6.Subjects with active infection or blood supply limitations.
•7.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
•8.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
•9.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C = 10).
•10.Subjects with a history of heavy smoking ( > 20 cigarettes/day) within the last 6 months.
•11.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
•12.Subjects who are pregnant or lactating at the time of screening

发起方