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

NCT ID: NCT02801474

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Posterior Malleolus Fractures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

direct fracture reduction and fixation

Intervention Type: PROCEDURE

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 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.

Group Type: EXPERIMENTAL

indirect fracture reduction and fixation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• open fractures
• pathological fractures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Jin XIONG

Director in the Department of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin XIONG, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28292290 (View on PubMed)

Other Identifiers

115690

Identifier Type: -

Identifier Source: org_study_id