Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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German Clinical Trials Register |
Last refreshed on:
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8 April 2024 |
Main ID: |
DRKS00009911 |
Date of registration:
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28/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Functional Outcome of therapy of elbow dislocation - medium- and long-term results of conservative and surgical therapy of elbow dislocations with or without related fractures
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Scientific title:
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Functional Outcome of therapy of elbow dislocation - medium- and long-term results of conservative and surgical therapy of elbow dislocations with or without related fractures |
Date of first enrolment:
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02/03/2015 |
Target sample size:
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100 |
Recruitment status: |
Recruiting |
URL:
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http://drks.de/search/en/trial/DRKS00009911 |
Study type:
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observational |
Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Dorothee
Gühring |
Address:
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Schnarrenbergstr.95
72076
Tübingen
Germany |
Telephone:
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07071 - 606 - 0 (Pforte BGU) |
Email:
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dguehring@bgu-tuebingen.de |
Affiliation:
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Berufsgenossenschaftliche Unfallklinik Tübingen |
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Name:
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Markus
Gühring |
Address:
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Schnarrenbergstr.95
72076
Tübingen
Germany |
Telephone:
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07071 - 606 - 0 (Pforte BGU) |
Email:
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mguehring@bgu-tuebingen.de |
Affiliation:
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Berufsgenossenschaftliche Unfallklinik Tübingen |
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Key inclusion & exclusion criteria
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Inclusion criteria: conservative or surgical therapy of elbow dislocation in the space of time from January 2010 to December 2012
Exclusion criteria: Patient refuses to take part at the study. It's not possible for the patient to appear to the follow-up examination and to be interviewed.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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S53
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Dislocation, sprain and strain of joints and ligaments of elbow
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Intervention(s)
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Group 1: conservative therapy: closed reduction (splint or dynamic splint for at least two weeks) Questionnaire asking them to agility, strength and stability of the elbow in everyday life, in Sport and at work, as well as the acute pain and the functionality of the elbow . Assessment using various scores. Group 2: surgical therapy: open reduction (screws, pins)
Questionnaire asking them to agility, strength and stability of the elbow in everyday life, in Sport and at work, as well as the acute pain and the functionality of the elbow . Assessment using various scores.
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Primary Outcome(s)
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Elbow function (movement, strength, pain, stability) and consequences on quality of Life by questionnaire and examination according to the following scores: VAS, DASH, Score of Broberg and Morrey, MEPI, EuroQol-5D The Primary Outcome is set on a date when the therapy is at least finished for one year.
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Secondary Outcome(s)
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long-term outcome and complications (questionnaire) The Secondary Outcome is evaluated five years after having finished the treatment.
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Source(s) of Monetary Support
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Berufsgenossenschaftliche Unfallklinik Tübingen
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Ethics review
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Status: Approved
Approval date: 11/01/2016
Contact:
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