NCT03064399

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

February 22, 2017

Last Update Submit

February 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Function score

    AOFAS ankle function score

    One year after surgery

Secondary Outcomes (1)

  • Imaging result

    One year after surgery

Study Arms (2)

lateral ligament repairment

EXPERIMENTAL
Procedure: lateral ligament repairment

without lateral ligament repairment

EXPERIMENTAL
Procedure: without lateral ligament repairment

Interventions

microfracture without repairment of the lateral ligament

without lateral ligament repairment

microfracture combined with repairment of the lateral ligament

lateral ligament repairment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full - thickness cartilage injury

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Central Study Contacts

Yunfeng Yang, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 27, 2017

Study Start

February 28, 2017

Primary Completion

May 28, 2019

Study Completion

February 28, 2020

Last Updated

February 27, 2017

Record last verified: 2017-02