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

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.

Study Overview

• Status: Completed
• Conditions: Posterior Malleolus Fractures
• Intervention / Treatment: Procedure: direct fracture reduction and fixation; Procedure: indirect fracture reduction and fixation

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• open fractures
• pathological fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: direct reduction; Intervention: The posterior and lateral malleoli were accessed via a posterolateral approach with the patients in prone position. The fibular fracture was exposed and reduced anatomically in the first place. The posterior malleolus was then exposed between the fiexor halluces longus and peroneus longus interval. The posterior malleolar fragment was then reduced with reference to the typical metaphyseal-diaphyseal spike of the posterior malleolus. One-third tubular plate, reconstruction plate, or distal radius plate were applied spanning the fracture in a buttress mode. Cannulated screws could also be used.	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.
Experimental: indirect reduction; Intervention: After open reduction and internal fixation of lateral and medial malleolar fractures, the posterior malleolus was then reduced through ligamentotaxis with the ankle in dorsiflexion. One or two 4.0 mm cannulated screws were used to fix the posterior malleolar in anterior-to-posterior direction.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
American Orthopaedic Foot and Ankle Society ankle-hindfoot score	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
ankle range of motion in degrees	1 year
residual displacement of the posterior malleolus in mm	3 days postoperatively

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Principal Investigator: Jin XIONG, M.D., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

General Publications

• Shi HF, Xiong J, Chen YX, Wang JF, Qiu XS, Huang J, Gui XY, Wen SY, Wang YH. Comparison of the direct and indirect reduction techniques during the surgical management of posterior malleolar fractures. BMC Musculoskelet Disord. 2017 Mar 14;18(1):109. doi: 10.1186/s12891-017-1475-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 12, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 115690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO