Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

Ankle Fractures Clinical Trial

Official title:

Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02977910
• Other study ID #: 56014768-4
• Status: Not yet recruiting
• Phase: N/A
• First received: November 23, 2016
• Last updated: November 26, 2016
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ankle fracture with deltoid ligament rupture

Exclusion Criteria:

• ankle fracture without deltoid ligament rupture

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Rupture

Intervention

Procedure:
• repair of deltoid ligament
intraoperative repair of deltoid ligament combined with ORIF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liming Cheng

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS score		12 months after surgery	Yes