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AORIF Complex Ankle Fractures

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ClinicalTrials.gov Identifier: NCT04033848
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sebastian. F. Baumbach, 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.

Condition or disease Intervention/treatment
Ankle Fractures Procedure: Arthroscopic assisted ankle fracture 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)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Arthroscopically Assisted Treatment of Complex Ankle Fractures - Intraarticular Findings and Prospective PROM Follow-Up
Actual Study Start Date : May 1, 2013
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. OMAS [ Time Frame: Through study completion, an average of 1 year ]
    Olerud and Molander Ankle Score; Validated PROM; Range 0-100


Secondary Outcome Measures :
  1. ICRS: Clinical Cartilage Injury Evaluation System [ Time Frame: IntraOP ]
    Intraarticular cartilage lesions and treatment

  2. FAAM [ Time Frame: Through study completion, an average of 1 year ]
    Foot and Ankle Ability Measure, Validated PROM; Range 0-100

  3. AOFAS [ Time Frame: Through study completion, an average of 1 year ]
    American Orthopaedic Foot and Ankle Society, Validated PROM; Range 0-100

  4. FAOS [ Time Frame: Through study completion, an average of 1 year ]
    Foot and Ankle Outcome Score, Validated PROM; Range 0-100

  5. TAS [ Time Frame: Through study completion, an average of 1 year ]
    Tegener Activity Scale, Validated PROM; Range 0-10

  6. SF-12 [ Time Frame: Through study completion, an average of 1 year ]
    Quality of life score, Validated PROM; Range 0-100

  7. EQ-5d [ Time Frame: Through study completion, an average of 1 year ]
    Quality of life score, Validated PROM; Range 0-100

  8. MoxFQ [ Time Frame: Through study completion, an average of 1 year ]
    The Manchester-Oxford Foot Questionnaire, Validated PROM; Range 0-100



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient are being recruted from the investigator's ER or foot and ankle outpatient deparment
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033848


Contacts
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Contact: Sebastian F Baumbach, MD 0049894400 ext 519474 sebastian.baumbach@med.uni-muenchen.de
Contact: Hans Polzer, MD 0049894400 ext 52511 hans.polzer@med.uni-muenchen.de

Locations
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Germany
Department of Trauma Surgery, Medical University of Munich Recruiting
Munich, Germany, 80336
Contact: Sebastian F. Baumbach, M.D.       sebastian.baumbach@med.uni-muenchen.de   
Principal Investigator: Sebastian F. Baumbach, M.D.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Study Chair: Wolfgang Böcker, MD LMU Munich

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Responsible Party: Sebastian. F. Baumbach, Principle Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT04033848     History of Changes
Other Study ID Numbers: AZ 117-15
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared on reasonable demand / colaboration

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich:
Arthroscopy
Ankle Fracture
Patient rated outcome
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries