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Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment

Primary Purpose

Lateral Ligament Repair, Talar Cartilage Lesion, Microfracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
without lateral ligament repairment
lateral ligament repairment
Sponsored by
Shanghai Tongji Hospital, Tongji University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Ligament Repair

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Full - thickness cartilage injury

Exclusion Criteria:

Age: > 40 years old or < 18 years old; BMI > 30; lesion > 4 cm2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    lateral ligament repairment

    without lateral ligament repairment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Function score
    AOFAS ankle function score

    Secondary Outcome Measures

    Imaging result
    Anatomical data from imaging results when bearing

    Full Information

    First Posted
    February 22, 2017
    Last Updated
    February 22, 2017
    Sponsor
    Shanghai Tongji Hospital, Tongji University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03064399
    Brief Title
    Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment
    Official Title
    Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 28, 2017 (Anticipated)
    Primary Completion Date
    May 28, 2019 (Anticipated)
    Study Completion Date
    February 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Tongji Hospital, Tongji University School of Medicine

    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
    To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lateral Ligament Repair, Talar Cartilage Lesion, Microfracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    lateral ligament repairment
    Arm Type
    Experimental
    Arm Title
    without lateral ligament repairment
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    without lateral ligament repairment
    Intervention Description
    microfracture without repairment of the lateral ligament
    Intervention Type
    Procedure
    Intervention Name(s)
    lateral ligament repairment
    Intervention Description
    microfracture combined with repairment of the lateral ligament
    Primary Outcome Measure Information:
    Title
    Function score
    Description
    AOFAS ankle function score
    Time Frame
    One year after surgery
    Secondary Outcome Measure Information:
    Title
    Imaging result
    Description
    Anatomical data from imaging results when bearing
    Time Frame
    One year after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Full - thickness cartilage injury Exclusion Criteria: Age: > 40 years old or < 18 years old; BMI > 30; lesion > 4 cm2
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yunfeng Yang, Doctor
    Phone
    +86 13918588939

    12. IPD Sharing Statement

    Learn more about this trial

    Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment

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