Clinical trial NCT02971943: Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injury
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with excellent effects
timeFrame: at postoperative 3 months
Secondary outcomes:
measure: patients with Lauge-Hansen classification
timeFrame: baseline
measure: X-ray examination
timeFrame: baseline and 3 months postoperatively
measure: MRI findings
timeFrame: baseline and 3 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Hebei Medical University
name: Guobin Liu, Master
role: PRINCIPAL_INVESTIGATOR
References: