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.

Study Overview

• Status: Completed
• Conditions: Ligament Injury
• Intervention / Treatment: Device: Y-Knot all-suture anchor; Device: Biocomposite suture anchor

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • Sichuan Orthopedics Hospital
  • Jinan, China
    • Qilu Hospital of Shandong University
  • Shenzhen, China
    • Shenzhen Second People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Huashan Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ConMed Linvatec Beijing

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Actual): May 5, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: P18101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No