Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment
February 22, 2017 updated by: Liming Cheng, Shanghai Tongji Hospital, Tongji University School of Medicine
Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Full - thickness cartilage injury
Exclusion Criteria:
Age: > 40 years old or < 18 years old; BMI > 30; lesion > 4 cm2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: lateral ligament repairment
|
microfracture combined with repairment of the lateral ligament
|
|
Experimental: without lateral ligament repairment
|
microfracture without repairment of the lateral ligament
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function score
Time Frame: One year after surgery
|
AOFAS ankle function score
|
One year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Imaging result
Time Frame: One year after surgery
|
Anatomical data from imaging results when bearing
|
One year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 28, 2017
Primary Completion (Anticipated)
May 28, 2019
Study Completion (Anticipated)
February 28, 2020
Study Registration Dates
First Submitted
February 22, 2017
First Submitted That Met QC Criteria
February 22, 2017
First Posted (Actual)
February 27, 2017
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 56014768-5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.