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Clinical Trial Summary

Patients with a posterior malleolar fracture were recruited and assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture, the quality of fracture reduction was evaluated in radiograph and CT images. Functional outcome was evaluated at the last follow-up.


Clinical Trial Description

Patients with a posterior malleolus fracture were recruited meeting the inclusion criteria of unstable and displaced posterior malleolar fractures requiring surgical management. Patients with open fractures or pathological fractures were excluded. Preoperative anteroposterior (AP), lateral, and mortise view radiographs as well as computed tomography (CT) scans were routinely obtained to evaluate the characteristic of the fracture. Patients were then assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture using the direct reduction technique or the indirect reduction technique, the quality of fracture reduction was evaluated in radiograph and CT images. Functional outcome,including AOFAS score, ankle range of motion were evaluated at the last follow-up. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02801474
Study type Interventional
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact
Status Completed
Phase N/A
Start date January 2012
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT05084794 - The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed N/A
Recruiting NCT05413707 - Weber B Ankle Fractures With Associated Posterior Malleolus Fracture N/A
Recruiting NCT03107767 - Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures N/A