Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging
Primary Purpose
Ankle Injury
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
internal fixation for ankle fractures
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injury
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
internal fixation for ankle fractures
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of patients with excellent effects
higher value indicates better repair effect
Secondary Outcome Measures
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.
X-ray examination
To evaluate the healing degree of fracture
MRI findings
To evaluate ligament repair effects
Full Information
NCT ID
NCT02971943
First Posted
November 16, 2016
Last Updated
November 20, 2016
Sponsor
The First Hospital of Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02971943
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Hospital of Hebei Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected.
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.
The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
internal fixation for ankle fractures
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
internal fixation for ankle fractures
Intervention Description
The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.
Primary Outcome Measure Information:
Title
Percentage of patients with excellent effects
Description
higher value indicates better repair effect
Time Frame
at postoperative 3 months
Secondary Outcome Measure Information:
Title
patients with Lauge-Hansen classification
Description
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.
Time Frame
baseline
Title
X-ray examination
Description
To evaluate the healing degree of fracture
Time Frame
baseline and 3 months postoperatively
Title
MRI findings
Description
To evaluate ligament repair effects
Time Frame
baseline and 3 months postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guobin Liu, Master
Organizational Affiliation
The First Affiliated Hospital of Hebei Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging
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