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Clinical Trials/NCT02801474
NCT02801474
Completed
Not Applicable

Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country148 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posterior Malleolus Fractures
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
148
Locations
1
Primary Endpoint
American Orthopaedic Foot and Ankle Society ankle-hindfoot score
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Principal Investigator
Principal Investigator

Jin XIONG

Director in the Department of Orthopaedics

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

Inclusion Criteria

  • unstable ankle fracture requiring surgical intervention
  • with posterior malleolar fracture

Exclusion Criteria

  • open fractures
  • pathological fractures

Outcomes

Primary Outcomes

American Orthopaedic Foot and Ankle Society ankle-hindfoot score

Time Frame: 1 year

Secondary Outcomes

  • ankle range of motion in degrees(1 year)
  • residual displacement of the posterior malleolus in mm(3 days postoperatively)

Study Sites (1)

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