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

Posterior Malleolus Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801474
• Other study ID #: 115690
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: June 15, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• unstable ankle fracture requiring surgical intervention

• with posterior malleolar fracture

Exclusion Criteria:

• open fractures

• pathological fractures

Study Design

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Posterior Malleolus Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopaedic Foot and Ankle Society ankle-hindfoot score		1 year	No
Secondary	ankle range of motion in degrees		1 year	No
Secondary	residual displacement of the posterior malleolus in mm		3 days postoperatively	No