AORIF Complex Ankle Fractures

July 23, 2019 updated by: Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80336
        • Recruiting
        • Department of Trauma Surgery, Medical University of Munich
        • Contact:
        • Principal Investigator:
          • Sebastian F. Baumbach, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient are being recruted from the investigator's ER or foot and ankle outpatient deparment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OMAS
Time Frame: Through study completion, an average of 1 year
Olerud and Molander Ankle Score; Validated PROM; Range 0-100
Through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Study Chair: Wolfgang Böcker, MD, LMU Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 117-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared on reasonable demand / colaboration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankle Fractures

Clinical Trials on Arthroscopic assisted ankle fracture treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe