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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ligament Injury

Intervention / Treatment
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* Device: Y-Knot all-suture anchor
* Device: Biocomposite suture anchor


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Y-Knot group<br>Patients use Y-Knot all-suture anchor | Device: Y-Knot all-suture anchor<br>* Y-knot all-suture anchor will be implanted to participants<br>|
| Active Comparator: Biocomposite suture anchor<br>Patients use Biocomposite suture anchor | Device: Biocomposite suture anchor<br>* Biocomposite suture anchor will be implanted to participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of AOFAS score |  | From pre-operation to 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of AOFAS score |  | From pre-operation to 3 months postoperative | 
| Improvement of VAS score |  | From pre-operation to 3 and 6 months postoperative | 
| ligament injury recurrences |  | up to 6 months postoperative | 
| secondary surgery |  | up to 6 months postoperative |