AORIF Complex Ankle Fractures

Last updated: July 23, 2019
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04033848
AZ 117-15
  • Ages 18-100
  • All Genders

Study Summary

The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Unimalleolar fracture + ligamentous injury

  • Bi- or trimalleolar fracture ± ligamentous injury

  • > 17 years

  • Date of injury less than 15 days

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Isolated unimalleolar fracture

  • Pilon fracture

  • Open fracture

  • Mental illness, incompliance, pregnancy

  • Multiple injuries

Study Design

Total Participants: 100
Study Start date:
May 01, 2013
Estimated Completion Date:
May 31, 2021

Study Description

Starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. A complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. An unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. Exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy.

Data assessed are:

  • Demographics

  • Medical history

  • Classification (AO, Haraguchi, ICRS, location and size defect)

  • Surgery details

  • Complications

  • PROMs (FAAM, AOFAS, OMAS, FAOS, TAS, SF-12, EQ-5d, MoxFQ)

Connect with a study center

  • Department of Trauma Surgery, Medical University of Munich

    Munich, 80336
    Germany

    Active - Recruiting

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