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
About this trial
This is an interventional treatment trial for Lateral Ligament Repair
Eligibility Criteria
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
NCT ID
NCT03064399
First Posted
February 22, 2017
Last Updated
February 22, 2017
Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
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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