Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

November 26, 2016 updated by: Liming Cheng

Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ankle fracture with deltoid ligament rupture

Exclusion Criteria:

  • ankle fracture without deltoid ligament rupture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: with repair of deltoid ligament
open reduction and internal fixation with repair of deltoid ligament
Procedure: repair of deltoid ligament
intraoperative repair of deltoid ligament combined with ORIF
NO_INTERVENTION: without repair of deltoid ligament
open reduction and internal fixation without repair of deltoid ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AOFAS score
Time Frame: 12 months after surgery
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liming Cheng

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 26, 2016

First Posted (ESTIMATE)

November 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 26, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56014768-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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