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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02801474
Enrollment
148
Registered
2016-06-15
Start date
2012-01-31
Completion date
2015-12-31
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Malleolus Fractures

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.

Interventions

PROCEDUREdirect 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.

PROCEDUREindirect 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.

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* open fractures * pathological fractures

Design outcomes

Primary

MeasureTime frame
American Orthopaedic Foot and Ankle Society ankle-hindfoot score1 year

Secondary

MeasureTime frame
ankle range of motion in degrees1 year
residual displacement of the posterior malleolus in mm3 days postoperatively

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026