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

NCT02801474 | Completed DMC

• 1 other identifier: 115690
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Malleolus Fractures

Outcome Measures

Primary Outcomes (1)

• American Orthopaedic Foot and Ankle Society ankle-hindfoot score

  1 year

Secondary Outcomes (2)

• ankle range of motion in degrees

  1 year

• residual displacement of the posterior malleolus in mm

  3 days postoperatively

Study Arms (2)

direct reduction

EXPERIMENTAL

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

indirect reduction

EXPERIMENTAL

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

Interventions

direct fracture reduction and fixation 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.

direct reduction

indirect fracture reduction and fixation 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.

indirect reduction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• open fractures
• pathological fractures

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• 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.

  PMID: 28292290 DERIVED

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Jin XIONG, M.D.

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director in the Department of Orthopaedics

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 15, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)