Status:
COMPLETED
A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
Lead Sponsor:
ConMed Linvatec Beijing
Conditions:
Ligament Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04310956
Start Date
December 23 2019
End Date
December 1 2021
Last Update
March 9 2022
Active Locations (4)
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1
Huashan Hosptial
Shanghai, Shanghai Municipality, China, 200000
2
Sichuan Orthopedics Hospital
Chengdu, China
3
Qilu Hospital of Shandong University
Jinan, China
4
Shenzhen Second People's Hospital
Shenzhen, China