A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
Not Applicable
Completed
- Conditions
- Ligament Injury
- 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
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
- 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)
Huashan Hosptial
🇨🇳Shanghai, Shanghai, China
Sichuan Orthopedics Hospital
🇨🇳Chengdu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, China
Huashan Hosptial🇨🇳Shanghai, Shanghai, China