NCT04033848

AORIF Complex Ankle Fractures

Arthroscopically Assisted Treatment of Complex Ankle Fractures - Intraarticular Findings and Prospective PROM Follow-Up

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic assisted ankle fracture treatment	Any complex ankle fracture, as discriped above, will be treated arthroscopically and will be prospectively followed-up using well validated PROMs

Timeline

• Start date: 2013-05-01
• Primary completion: 2020-05-01
• Completion: 2021-05-01
• First posted: 2019-07-26
• Last updated: 2019-07-26

Locations

1 site across 1 country: Germany