AORIF Complex Ankle Fractures

NCT ID: NCT04033848

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-01

Study Completion Date

2021-05-31

Brief Summary

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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

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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

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Ankle Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Sebastian. F. Baumbach

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfgang Böcker, MD

Role: STUDY_CHAIR

LMU Munich

Locations

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Department of Trauma Surgery, Medical University of Munich

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sebastian F Baumbach, MD

Role: CONTACT

0049894400 ext. 519474

Hans Polzer, MD

Role: CONTACT

0049894400 ext. 52511

Facility Contacts

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Sebastian F. Baumbach, M.D.

Role: primary

Other Identifiers

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AZ 117-15

Identifier Type: -

Identifier Source: org_study_id

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