A prospective, single-arm, multi-centre, post-marketing clinical follow-up study to evaluate the safety and performance of Bioabsorbable Ligament Anchor in Shoulder Rotator Cuff Repair

Chetan Meditech Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年12月19日

试验速览

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•1. Subject with chronic symptomatic rotator cuff tear ( > 6 weeks old) who has failed non-operative treatment.
•2. Male or female subject =18 years of age at time of surgery.
•3. Subject has provided consent to participate in the study by signing Ethics Committee (EC) approved informed consent form.
•4. Subject willing to comply with all the study follow-up procedures and requirements.

•1.Hypersensitivity to the implant material.
•2.Patients requiring artificial ligaments to attach in rotator cuff repair.
•3.Acute or chronic local or systemic infection.
•4.Patients with insufficient or immature bone.
•5.Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
•6.Pathological conditions of bone & soft tissue, such as cystic changes, tumor or severe osteopenia.
•7.Patient conditions including blood supply limitation and previous infections.
•8.Comminuted bone surface.
•9.Fracture or dislocation of the shoulder joint.
•10.Pregnant women.
•11.Prior ipsilateral surgeries performed on the joint space.
•12.Patients with a medical or physical condition that, in the opinion of Investigator, would preclude safe participation in the study.
•13.Participating in another investigational trial or ongoing study that would interfere with the outcomes assessment of this study.

发起方

Chetan Meditech Pvt Ltd