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

Ankle Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971943
• Other study ID #: FirstHebei_001
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 20, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: The First Hospital of Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Hebei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with excellent effects	higher value indicates better repair effect	at postoperative 3 months	No
Secondary	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	No
Secondary	X-ray examination	To evaluate the healing degree of fracture	baseline and 3 months postoperatively	No
Secondary	MRI findings	To evaluate ligament repair effects	baseline and 3 months postoperatively	No