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

Ligament Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310956
• Other study ID #: P18101
• Status: Completed
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2021
• Source: ConMed Linvatec Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 1, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Ligament Injury
• Wounds and Injuries

Intervention

Device:
• Y-Knot all-suture anchor
Y-knot all-suture anchor will be implanted to participants
• Biocomposite suture anchor
Biocomposite suture anchor will be implanted to participants

Locations

Country	Name	City	State
China	Sichuan Orthopedics Hospital	Chengdu
China	Qilu Hospital of Shandong University	Jinan
China	Huashan Hosptial	Shanghai	Shanghai
China	Shenzhen Second People's Hospital	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
ConMed Linvatec Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of AOFAS score		From pre-operation to 6 months postoperative
Secondary	improvement of AOFAS score		From pre-operation to 3 months postoperative
Secondary	Improvement of VAS score		From pre-operation to 3 and 6 months postoperative
Secondary	ligament injury recurrences		up to 6 months postoperative
Secondary	secondary surgery		up to 6 months postoperative