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

Primary Purpose

Posterior Malleolus Fractures

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
direct fracture reduction and fixation
indirect fracture reduction and fixation
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Malleolus Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • open fractures
  • pathological fractures

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

direct reduction

indirect reduction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

American Orthopaedic Foot and Ankle Society ankle-hindfoot score

Secondary Outcome Measures

ankle range of motion in degrees
residual displacement of the posterior malleolus in mm

Full Information

First Posted
June 1, 2016
Last Updated
June 15, 2016
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02801474
Brief Title
Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques
Official Title
Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Malleolus Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
direct reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
indirect reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
direct fracture reduction and fixation
Intervention Description
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
Intervention Name(s)
indirect fracture reduction and fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society ankle-hindfoot score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ankle range of motion in degrees
Time Frame
1 year
Title
residual displacement of the posterior malleolus in mm
Time Frame
3 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unstable ankle fracture requiring surgical intervention with posterior malleolar fracture Exclusion Criteria: open fractures pathological fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin XIONG, M.D.
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28292290
Citation
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.
Results Reference
derived

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

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