NCT02801474

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Posterior Malleolus Fractures

Interventions

Type	Name	Description
PROCEDURE	direct fracture reduction and fixation	In the DR group, the posterior malleolar fracture was reduced and fixed in a direct way via a posterolateral approach with the patients in prone position.
PROCEDURE	indirect fracture reduction and fixation	In the IR group, the posterior malleolus was reduced through ligamentotaxis following open reduction and internal fixation of lateral and medial malleolar fractures. Percutaneous cannulated screws were used to fix the posterior malleolar in anterior-to-posterior direction.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-06-15
• Last updated: 2016-06-17

Locations

1 site across 1 country: China