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AORIF Complex Ankle Fractures

L

Ludwig Maximilian University of Munich

Status

Unknown

Conditions

Ankle Fractures

Treatments

Procedure: Arthroscopic assisted ankle fracture treatment

Study type

Observational

Funder types

Other

Identifiers

NCT04033848
AZ 117-15

Details and patient eligibility

About

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.

Full 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)

Enrollment

100 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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 criteria

  • Isolated unimalleolar fracture
  • Pilon fracture
  • Open fracture
  • Mental illness, incompliance, pregnancy
  • Multiple injuries

Trial contacts and locations

1

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Central trial contact

Hans Polzer, MD; Sebastian F Baumbach, MD

Data sourced from clinicaltrials.gov

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