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

CONMED

Status

Completed

Conditions

Ligament Injury

Treatments

Device: Biocomposite suture anchor

Device: Y-Knot all-suture anchor

Study type

Interventional

Funder types

Industry

Identifiers

NCT04310956

P18101

Details and patient eligibility

About

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.

Enrollment

148 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;