Comparative Study of Postieror Ankle Fracture

February 22, 2017 updated by: Liming Cheng, Shanghai Tongji Hospital, Tongji University School of Medicine

Comparative Study of Postieror Malleolar Fracture With Plate and Screw Fixation

To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

supination-external rotation Ⅳ type injury

Exclusion Criteria:

Pion fracture; Isolated posterior ankle fracture.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: plate group
internal fixation with the plate
Procedure: Plate fixation
internal fixation with the plate
Experimental: screw group
internal fixation with the screw
Procedure: Screw fixation
internal fixation with the screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional score
Time Frame: One year after surgery
AOFAS function score for ankle
One year after surgery

Collaborators and Investigators

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

Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

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 (Anticipated)

February 28, 2017

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56014768-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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