Ligament Injury
Conditions
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.
Interventions
DEVICEY-Knot all-suture anchor
Y-knot all-suture anchor will be implanted to participants
DEVICEBiocomposite suture anchor
Biocomposite suture anchor will be implanted to participants
Sponsors
ConMed Linvatec Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of AOFAS score | From pre-operation to 6 months postoperative |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed