Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance ofAUXILOCK Shoulder Arthroscopy System - Nil

Auxein Medical Pvt Ltd0 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

研究概览

暂无简介。

•? Subject is willing and able to give Written informed consent for participation.
•? No history of surgery on affected Shoulder.
•? Male or Female, aged between 18 to 75 years.
•? Subject scheduled for Shoulder arthroscopic surgery for fixation of Shoulder related
•ligaments and tendons repair.

•? Subject having any local active infections, blood supply limitations, diseases or other
•systemic conditions that may retard healing or create unacceptable risk of fixation failure.
•? Subject having inadequate tissue coverage on the operative site, where suture anchor
•performances would be compromised.
•? Subject having foreign body sensitivities where precautionary or mitigation methods are
•inadequate to control the conditions.
•? Subjects with substance abuse/alcohol issues.
•? Subjects who are incarcerated or have pending incarceration.
•? Subjects with mental disorders
•? Subject who has contraindication mentioned in the IFU.
•? Female participant who is pregnant or planning pregnancy during the course of the clinical
•? Subjects inability or unwillingness to follow surgeon’s prescribed post-operative care after
•shoulder arthroscopy surgery.

发起方

Auxein Medical Pvt Ltd