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Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

L

Liming Cheng

Status

Unknown

Conditions

Ankle Fractures

Treatments

Procedure: repair of deltoid ligament

Study type

Interventional

Funder types

Other

Identifiers

NCT02977910
56014768-4

Details and patient eligibility

About

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.

Full description

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

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ankle fracture with deltoid ligament rupture

Exclusion criteria

  • ankle fracture without deltoid ligament rupture

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups

with repair of deltoid ligament
Experimental group
Description:
open reduction and internal fixation with repair of deltoid ligament
Treatment:
Procedure: repair of deltoid ligament
without repair of deltoid ligament
No Intervention group
Description:
open reduction and internal fixation without repair of deltoid ligament

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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