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

Microfracture Clinical Trial

Official title:

Microfracture Technique for the Treatment of Articular Cartilage Lesions of the Talus With or Without Lateral Ligament Repairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03064399
• Other study ID #: 56014768-5
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: February 22, 2017
• Start date: February 28, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2017
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: Yunfeng Yang, Doctor
• Phone: +86 13918588939
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 28, 2020
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Full - thickness cartilage injury

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lateral Ligament Repair
• Microfracture
• Talar Cartilage Lesion

Intervention

Procedure:
• without lateral ligament repairment
microfracture without repairment of the lateral ligament
• lateral ligament repairment
microfracture combined with repairment of the lateral ligament

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function score	AOFAS ankle function score	One year after surgery
Secondary	Imaging result	Anatomical data from imaging results when bearing	One year after surgery