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

NCT ID: NCT04310956

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2021-12-01

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.

Conditions

Ligament Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Y-Knot group

Patients use Y-Knot all-suture anchor

Group Type: EXPERIMENTAL

Y-Knot all-suture anchor

Intervention Type: DEVICE

Y-knot all-suture anchor will be implanted to participants

Biocomposite suture anchor

Patients use Biocomposite suture anchor

Group Type: ACTIVE_COMPARATOR

Biocomposite suture anchor

Intervention Type: DEVICE

Biocomposite suture anchor will be implanted to participants

Interventions

Y-Knot all-suture anchor

Y-knot all-suture anchor will be implanted to participants

Intervention Type: DEVICE

Biocomposite suture anchor

Biocomposite suture anchor will be implanted to participants

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConMed Linvatec Beijing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hosptial

Shanghai, Shanghai Municipality, China

Sichuan Orthopedics Hospital

Chengdu, , China

Qilu Hospital of Shandong University

Jinan, , China

Shenzhen Second People's Hospital

Shenzhen, , China

Countries

China

Other Identifiers

P18101

Identifier Type: -

Identifier Source: org_study_id