AORIF Complex Ankle Fractures

• Conditions: Ankle Fractures

• Registration Number: NCT04033848
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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)

Study Timeline

• Study Start: 2013-05-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26
• Primary Completion: 2020-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OMAS	Through study completion, an average of 1 year	Olerud and Molander Ankle Score; Validated PROM; Range 0-100

Secondary Outcome Measures

Name	Time	Method
SF-12	Through study completion, an average of 1 year	Quality of life score, Validated PROM; Range 0-100
ICRS: Clinical Cartilage Injury Evaluation System	IntraOP	Intraarticular cartilage lesions and treatment
TAS	Through study completion, an average of 1 year	Tegener Activity Scale, Validated PROM; Range 0-10
EQ-5d	Through study completion, an average of 1 year	Quality of life score, Validated PROM; Range 0-100
FAAM	Through study completion, an average of 1 year	Foot and Ankle Ability Measure, Validated PROM; Range 0-100
AOFAS	Through study completion, an average of 1 year	American Orthopaedic Foot and Ankle Society, Validated PROM; Range 0-100
MoxFQ	Through study completion, an average of 1 year	The Manchester-Oxford Foot Questionnaire, Validated PROM; Range 0-100
FAOS	Through study completion, an average of 1 year	Foot and Ankle Outcome Score, Validated PROM; Range 0-100

Trial Locations

Locations (1)

Department of Trauma Surgery, Medical University of Munich; 🇩🇪 Munich, Germany