A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Bankarts Repair using Knotted UHMWPE Suture 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8月19日

试验速览

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•1.Male and female subjects between 18 to 40 years of age.
•2.Subjects with Bankarts lesion requiring primary Arthroscopic Bankarts repair surgery.
•3.Subjects willing to give written informed consent to participate in the study.

•1.Subjects with BMI =35 kg/m2.
•2.Subjects with history of any surgery to the same shoulder.
•3.Subjects with active infection or blood supply limitations.
•4.Subjects with pathological conditions of bone or soft tissue that would impair secure fixation.
•5.Subjects with known hypersensitivity to UHMWPE
•6.Subjects with conditions, which would limit the subjects ability or willingness to restrict activities or follow directions during the healing period.
•7.Subjects having any condition that could affect healing (eg. Infections, Regular use of Corticosteroids, Diabetes – HbA1C = 10).
•8.Subjects with 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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