Clincosm LogoSign in Get a demo

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

Sponsor
ConMed Linvatec Beijing (Industry)
Overall Status
Completed
CT.gov ID
NCT04310956
Collaborator
(none)
148
Enrollment
4
Locations
2
Arms
23.3
Actual Duration (Months)
37
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Y-Knot all-suture anchor
  • Device: Biocomposite suture anchor
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 23, 2019
Actual Primary Completion Date :
May 5, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Y-Knot group

Patients use Y-Knot all-suture anchor

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

Patients use Biocomposite suture anchor

Device: Biocomposite suture anchor
Biocomposite suture anchor will be implanted to participants

Outcome Measures

Primary Outcome Measures

  1. improvement of AOFAS score [From pre-operation to 6 months postoperative]

Secondary Outcome Measures

  1. improvement of AOFAS score [From pre-operation to 3 months postoperative]

  2. Improvement of VAS score [From pre-operation to 3 and 6 months postoperative]

  3. ligament injury recurrences [up to 6 months postoperative]

  4. secondary surgery [up to 6 months postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hosptial Shanghai Shanghai China 200000
2 Sichuan Orthopedics Hospital Chengdu China
3 Qilu Hospital of Shandong University Jinan China
4 Shenzhen Second People's Hospital Shenzhen China

Sponsors and Collaborators

  • ConMed Linvatec Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ConMed Linvatec Beijing
ClinicalTrials.gov Identifier:
NCT04310956
Other Study ID Numbers:
  • P18101
First Posted:
Mar 17, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Mar 9, 2022