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

Not Applicable

Completed

• Conditions: Posterior Malleolus Fractures

• Registration Number: NCT02801474
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-06
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-15
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

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

Exclusion Criteria

• open fractures
• pathological fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot and Ankle Society ankle-hindfoot score	1 year

Secondary Outcome Measures

Name	Time	Method
ankle range of motion in degrees	1 year
residual displacement of the posterior malleolus in mm	3 days postoperatively

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China