A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair

A Multi-center, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair

Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.

Inclusion Criteria:

• Male or Female, no less than 18 years old;
• Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot&ankle repair surgery by investigator;
• Patient willing to sign a written consent form participating in this study；
• Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；
• Life expectancy is more than 2 years post-operationally;

Exclusion Criteria:

• Conducted surgery at index ankle and possibly influence the outcome evaluation;
• Bilateral ankle surgery;
• Suffering concurrent ankle disease that may leads to a surgery during the study phase;
• known or suspected allergies to implant and/or instrument materials;
• pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;
• With concurrent disease that may influence the index ankle function;
• Patients with active sepsis or infection;
• With concurrent disease that may influence the stability of device and rehabilitation;
• Immune suppression, impairment of immune function, or autoimmune disease;
• Pregnant or lactating women;
• Known noncompliance or lost follow-up risk;
• Participated other drug, biologic, or device clinical trial 12 months before enrollment;
• Alcohol or drug abuser;
• Other inappropriate condition based on investigator determination;