Clinical trial NCT04033848: AORIF Complex Ankle Fractures
Official title: Arthroscopically Assisted Treatment of Complex Ankle Fractures - Intraarticular Findings and Prospective PROM Follow-Up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Fractures
Keywords: Arthroscopy
Ankle Fracture
Patient rated outcome
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient are being recruted from the investigator's ER or foot and ankle outpatient deparment

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)

Eligibility criteria: 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

Primary outcomes:
measure: OMAS
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: ICRS: Clinical Cartilage Injury Evaluation System
timeFrame: IntraOP
measure: FAAM
timeFrame: Through study completion, an average of 1 year
measure: AOFAS
timeFrame: Through study completion, an average of 1 year
measure: FAOS
timeFrame: Through study completion, an average of 1 year
measure: TAS
timeFrame: Through study completion, an average of 1 year
measure: SF-12
timeFrame: Through study completion, an average of 1 year
measure: EQ-5d
timeFrame: Through study completion, an average of 1 year
measure: MoxFQ
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Trauma Surgery, Medical University of Munich
Study officials:
affiliation: LMU Munich
name: Wolfgang Böcker, MD
role: STUDY_CHAIR
References: