Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

Not Applicable

• Conditions: Ankle Fractures
• Interventions: Procedure: repair of deltoid ligament

• Registration Number: NCT02977910
• Lead Sponsor: Liming Cheng

Brief Summary

Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.

Detailed Description

Comparative study for ankle fracture combined with deltoid ligament rupture: with \& without repair of ligament

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-26
• Last Update Submitted: 2016-11-26
• Study First Posted: 2016-11-30
• Last Update Posted: 2016-11-30
• Study Start: 2017-01
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ankle fracture with deltoid ligament rupture

Exclusion Criteria

• ankle fracture without deltoid ligament rupture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with repair of deltoid ligament	repair of deltoid ligament	open reduction and internal fixation with repair of deltoid ligament

Primary Outcome Measures

Name	Time	Method
AOFAS score	12 months after surgery