NCT02971943

Brief Summary

To verify whether X-ray combined with MRI is able to carry out correct fracture classification and postoperative evaluation in patients with ankle fractures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

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

Study Start

First participant enrolled

May 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

November 16, 2016

Last Update Submit

November 20, 2016

Conditions

Ankle Injury

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with excellent effects

    higher value indicates better repair effect

    at postoperative 3 months

Secondary Outcomes (3)

  • patients with Lauge-Hansen classification

    baseline

  • X-ray examination

    baseline and 3 months postoperatively

  • MRI findings

    baseline and 3 months postoperatively

Study Arms (1)

internal fixation for ankle fractures

OTHER

The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging preoperatively and 3 months postoperatively.

Procedure: internal fixation for ankle fractures

Interventions

internal fixation for ankle fracturesPROCEDURE

The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.

internal fixation for ankle fractures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ankle fractures patients detected by X-ray
  • Highly suspected ankle ligament injury
  • History of obvious trauma
  • Complete clinical data
  • Irrespective of sex and age
  • Sign the informed consent

You may not qualify if:

  • Cardiopulmonary function cannot tolerate anesthesia or surgery
  • Open fractures of ankle joint
  • Old fracture of the ankle joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Injuries

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Guobin Liu, Master

    The First Affiliated Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 23, 2016

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

November 23, 2016

Record last verified: 2016-11