A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
Primary Purpose
Ligament Injury
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Y-Knot all-suture anchor
Biocomposite suture anchor
Sponsored by
About this trial
This is an interventional treatment trial for Ligament Injury
Eligibility Criteria
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;
Sites / Locations
- Huashan Hosptial
- Sichuan Orthopedics Hospital
- Qilu Hospital of Shandong University
- Shenzhen Second People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Y-Knot group
Biocomposite suture anchor
Arm Description
Patients use Y-Knot all-suture anchor
Patients use Biocomposite suture anchor
Outcomes
Primary Outcome Measures
improvement of AOFAS score
Secondary Outcome Measures
improvement of AOFAS score
Improvement of VAS score
ligament injury recurrences
secondary surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04310956
Brief Title
A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConMed Linvatec Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligament Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Y-Knot group
Arm Type
Experimental
Arm Description
Patients use Y-Knot all-suture anchor
Arm Title
Biocomposite suture anchor
Arm Type
Active Comparator
Arm Description
Patients use Biocomposite suture anchor
Intervention Type
Device
Intervention Name(s)
Y-Knot all-suture anchor
Intervention Description
Y-knot all-suture anchor will be implanted to participants
Intervention Type
Device
Intervention Name(s)
Biocomposite suture anchor
Intervention Description
Biocomposite suture anchor will be implanted to participants
Primary Outcome Measure Information:
Title
improvement of AOFAS score
Time Frame
From pre-operation to 6 months postoperative
Secondary Outcome Measure Information:
Title
improvement of AOFAS score
Time Frame
From pre-operation to 3 months postoperative
Title
Improvement of VAS score
Time Frame
From pre-operation to 3 and 6 months postoperative
Title
ligament injury recurrences
Time Frame
up to 6 months postoperative
Title
secondary surgery
Time Frame
up to 6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
Huashan Hosptial
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Sichuan Orthopedics Hospital
City
Chengdu
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair
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