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

NCT04310956 | Completed

• 1 other identifier: P18101
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• improvement of AOFAS score

  From pre-operation to 6 months postoperative

Secondary Outcomes (4)

• 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

Study Arms (2)

Y-Knot group

EXPERIMENTAL

Patients use Y-Knot all-suture anchor

Device: Y-Knot all-suture anchor

Biocomposite suture anchor

ACTIVE COMPARATOR

Patients use Biocomposite suture anchor

Device: Biocomposite suture anchor

Interventions

Y-Knot all-suture anchor DEVICE

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

Y-Knot group

Biocomposite suture anchor DEVICE

Biocomposite suture anchor will be implanted to participants

Biocomposite suture anchor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• ConMed Linvatec Beijing: lead

Study Sites (4)

Huashan Hosptial

Shanghai, Shanghai Municipality, 200000, China

Location

Sichuan Orthopedics Hospital

Chengdu, China

Location

Qilu Hospital of Shandong University

Jinan, China

Location

Shenzhen Second People's Hospital

Shenzhen, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: December 23, 2019
• Primary Completion: May 5, 2021
• Study Completion: December 1, 2021
• Last Updated: March 9, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)