Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT04310956
Eligibility Criteria:
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04310956
Study Brief:
Protocol Section:
NCT04310956