A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Rotator Cuff Tear Repair Using Knotted UHMWPE Suture Titanium Anchor.

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7月22日

试验速览

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•1.Male and female subjects between 30 to 70 years of age.
•2.Subjects with rotator cuff tear requiring primary arthroscopic rotator cuff tear repair surgery.
•3.Subject willing to give written informed consent to participate in the study.

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

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