NCT03064386

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

February 22, 2017

Last Update Submit

February 22, 2017

Conditions

Postieror Malleolar FractureTreatment

Outcome Measures

Primary Outcomes (1)

  • functional score

    AOFAS function score for ankle

    One year after surgery

Study Arms (2)

plate group

EXPERIMENTAL

internal fixation with the plate

Procedure: Plate fixation

screw group

EXPERIMENTAL

internal fixation with the screw

Procedure: Screw fixation

Interventions

Plate fixationPROCEDURE

internal fixation with the plate

plate group
Screw fixationPROCEDURE

internal fixation with the screw

screw group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • supination-external rotation Ⅳ type injury

You may not qualify if:

  • Pion fracture; Isolated posterior ankle fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yunfeng Yang, Ph.D.

CONTACT

+86 13918588939

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 27, 2017

Study Start

February 28, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2020

Last Updated

February 27, 2017

Record last verified: 2017-02