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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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
Sponsor: The First Hospital of Hebei Medical University

Current Primary Outcome: Percentage of patients with excellent effects [ Time Frame: at postoperative 3 months ]

higher value indicates better repair effect


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • patients with Lauge-Hansen classification [ Time Frame: baseline ]
    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 [ Time Frame: baseline and 3 months postoperatively ]
    To evaluate the healing degree of fracture
  • MRI findings [ Time Frame: baseline and 3 months postoperatively ]
    To evaluate ligament repair effects


Original Secondary Outcome: Same as current

Information By: The First Hospital of Hebei Medical University

Dates:
Date Received: November 16, 2016
Date Started: May 2015
Date Completion:
Last Updated: November 20, 2016
Last Verified: November 2016