Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
NCT ID: NCT01803789
Last Updated: 2017-11-06
Study Results
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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COMPLETED
NA
292 participants
INTERVENTIONAL
2013-05-31
2017-07-31
Brief Summary
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Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures.
Primary hypothesis:
In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single Kirschner Wire
Antegrade intramedullary fixation of with a single Kirschner wire.
Single Kirschner Wire
Double Kirschner Wire
Antegrade intramedullary fixation with double Kirschner wire.
Double Kirschner Wire
Interventions
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Single Kirschner Wire
Double Kirschner Wire
Eligibility Criteria
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Inclusion Criteria
* Trauma within 10 days before appearing in the study centre
* No specific medical treatment before
* Ability to fully understand the character and implications of the clinical trial
* Written or oral (in case of an injury of the dominant hand, if so attested by witnesses)consent
Exclusion Criteria
* Patient is not suitable for anaesthesia
* Other physical conditions or characteristics which made surgical interventions inappropriate or to risky (e.g. open fractures, polytrauma, pregnancy, acute infections, pathological fractures)
* Prior participation in this study (e.g. injury of the contralateral hand) or participation in other interventional studies with the same objective
* Physical or mental diseases which makes the consequent participation in diagnostic, therapy and the follow-up-examinations unlikely
* Lacking language skills
18 Years
ALL
No
Sponsors
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Deutsche Arthrose-Hilfe
OTHER
University Medicine Greifswald
OTHER
Responsible Party
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Prof. Dr. Andreas Eisenschenk
Prof. Dr.
Principal Investigators
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Andreas Eisenschenk, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medicine Greifswald
Locations
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University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Sana Clinical Centre Lichtenberg
Berlin, , Germany
Vivantes Hospital Am Urban
Berlin, , Germany
Trauma Hospital Berlin
Berlin, , Germany
University Medicine Düsseldorf
Düsseldorf, , Germany
District Hospital Gummersbach
Gummersbach, , Germany
BG Kliniken Bergmannstrost
Halle, , Germany
Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
Hamburg, , Germany
University Medicine Hamburg-Eppendorf
Hamburg, , Germany
Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
Ludwigshafen, , Germany
University Medicine Rostock
Rostock, , Germany
Municipal Clinic Solingen
Solingen, , Germany
Countries
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Other Identifiers
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1-2-KiWI
Identifier Type: -
Identifier Source: org_study_id