Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging

Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging: a Retrospective, Self-controlled, Clinical Trial With 3-month Follow-up

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

Study Overview

• Status: Completed
• Conditions: Ankle Injury
• Intervention / Treatment: Procedure: internal fixation for ankle fractures

Detailed Description

History and current related studies Intraarticular fractures and ruptures of ligaments around the joint often occur after ankle injury. Early correct treatment can effectively help joint repair, and reduce the incidence of serious complications. Ankle fractures are one of the common orthopedic fractures. X-ray is a common method for detecting ankle injury, can determine the fracture site, type and extent. However, X-ray is difficult to display ankle fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate fracture classification or formulate treatment programs.

Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can provide accurate imaging information. MRI can provide accurate preoperative assessment of clinical indicators for the rational formulation of treatment programs to reduce complications. The observation of ankle contusion observed by MRI is conducive to analyzing the mechanism of ankle joint injury.

Therefore, X-ray combined with MRI would perfectly verify soft tissue injury after ankle fractures so as to make effective surgical program.

Adverse events Adverse events including incision pain, incision nonunion, ankle pain, peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury. Severe adverse events are events occurred during clinical trial, including requiring hospitalization, prolonged hospitalization, disability, inability to work, life-threatening, or fatalities. If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.

Data collection, management, analysis and open-access

1. Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected.
2. Data were processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically. All data regarding this trial were preserved by the First Hospital, Hebei Medical University, China.
3. The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: internal fixation for ankle fractures; 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; The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with excellent effects	higher value indicates better repair effect	at postoperative 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients with Lauge-Hansen classification	According to the degree of bone and ligament injury, there are supination-external rotation (supination-eversion), pronation-external rotation (pronation-eversion), supination-adduction and pronation-abduction.	baseline
X-ray examination	To evaluate the healing degree of fracture	baseline and 3 months postoperatively
MRI findings	To evaluate ligament repair effects	baseline and 3 months postoperatively

Collaborators and Investigators

• Sponsor: The First Hospital of Hebei Medical University
• Investigators: Principal Investigator: Guobin Liu, Master, The First Affiliated Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 20, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 20, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Ankle Injuries
• Other Study ID Numbers: FirstHebei_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED