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

Not Applicable

Completed

• Conditions: Ligament Injury
• Interventions: Device: Biocomposite suture anchor; Device: Y-Knot all-suture anchor

• Registration Number: NCT04310956
• Lead Sponsor: ConMed Linvatec Beijing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-23
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Primary Completion: 2021-05-05
• Status Verified: 2021-08
• Study Completion: 2021-12-01
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biocomposite suture anchor	Biocomposite suture anchor	Patients use Biocomposite suture anchor
Y-Knot group	Y-Knot all-suture anchor	Patients use Y-Knot all-suture anchor

Primary Outcome Measures

Name	Time	Method
improvement of AOFAS score	From pre-operation to 6 months postoperative

Secondary Outcome Measures

Name	Time	Method
improvement of AOFAS score	From pre-operation to 3 months postoperative
ligament injury recurrences	up to 6 months postoperative
secondary surgery	up to 6 months postoperative
Improvement of VAS score	From pre-operation to 3 and 6 months postoperative

Trial Locations

Locations (4)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, China

Sichuan Orthopedics Hospital; 🇨🇳 Chengdu, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, China

Huashan Hosptial; 🇨🇳 Shanghai, Shanghai, China