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Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

NCT ID: NCT02977910

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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

Conditions

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Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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with repair of deltoid ligament

open reduction and internal fixation with repair of deltoid ligament

Group Type EXPERIMENTAL

repair of deltoid ligament

Intervention Type PROCEDURE

intraoperative repair of deltoid ligament combined with ORIF

without repair of deltoid ligament

open reduction and internal fixation without repair of deltoid ligament

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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repair of deltoid ligament

intraoperative repair of deltoid ligament combined with ORIF

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ankle fracture with deltoid ligament rupture

Exclusion Criteria

* ankle fracture without deltoid ligament rupture
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liming Cheng

OTHER

Sponsor Role lead

Responsible Party

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Liming Cheng

Director, Head of orthopedics, Pricipal investigator, Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

References

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Fan J, Zhang X, Luo Y, You GW, Ng WK, Yang YF. Tibiotalocalcaneal (TTC) arthrodesis with reverse PHILOS plate and medial cannulated screws with lateral approach. BMC Musculoskelet Disord. 2017 Jul 24;18(1):317. doi: 10.1186/s12891-017-1666-2.

Reference Type DERIVED
PMID: 28738797 (View on PubMed)

Other Identifiers

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56014768-4

Identifier Type: -

Identifier Source: org_study_id