AORIF Complex Ankle Fractures

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04033848
• Other study ID #: AZ 117-15
• Status: Recruiting
• Start date: May 1, 2013
• Est. completion date: May 2021

Study information

• Verified date: July 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: Sebastian F Baumbach, MD
• Phone: 0049894400
• Email: sebastian.baumbach[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Trauma Surgery, Medical University of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

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