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Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures (1-2-KiWI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803789
First Posted: March 4, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutsche Arthrose-Hilfe
Information provided by (Responsible Party):
Prof. Dr. Andreas Eisenschenk, University Medicine Greifswald
  Purpose

Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces.

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).


Condition Intervention
Fracture of Metacarpal Bone Device: Single Kirschner Wire Device: Double Kirschner Wire

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures

Resource links provided by NLM:


Further study details as provided by Prof. Dr. Andreas Eisenschenk, University Medicine Greifswald:

Primary Outcome Measures:
  • Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score [ Time Frame: 6 months after randomisation ]

Secondary Outcome Measures:
  • Malposition or angulation in the frontal and sagittal planes of max. 5° [ Time Frame: 6 months after randomisation ]
  • Shortening of the metacarpus >2mm [ Time Frame: 6 months after randomisation ]
  • Palmar angulation >30° [ Time Frame: 6 months after randomisation ]
  • Non-union/Pseudarthrosis [ Time Frame: 6 months after randomisation ]
  • Limitation of fist closure [ Time Frame: 6 months after randomisation ]
  • Flexion or extension lag [ Time Frame: 6 months after randomisation ]
  • Pain intensity <10 points (VAS) [ Time Frame: 6 months after randomisation ]
  • Duration of surgical intervention [ Time Frame: 6 months after randomisation ]
  • Rate of re-interventions [ Time Frame: 6 months after randomisation ]
  • Rate of infections [ Time Frame: 6 months after randomisation ]
  • Rate of perforation/dislocation/break of the fracture fixation devices [ Time Frame: 6 months after randomisation ]
  • Duration of inability to work [ Time Frame: 6 months after randomisation ]

Enrollment: 292
Study Start Date: May 2013
Study Completion Date: July 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single Kirschner Wire
Antegrade intramedullary fixation of with a single Kirschner wire.
Device: Single Kirschner Wire
Active Comparator: Double Kirschner Wire
Antegrade intramedullary fixation with double Kirschner wire.
Device: Double Kirschner Wire

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥18 years with a metacarpal V neck fracture with a palmar angulation and/or shortening and /or rotational deformity as determined on radiological diagnosis
  • 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:

  • Indications for conservative therapy
  • 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
  Contacts and Locations
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): NCT01803789


Locations
Germany
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Sana Clinical Centre Lichtenberg
Berlin, Germany, 10365
Vivantes Hospital Am Urban
Berlin, Germany, 10967
Trauma Hospital Berlin
Berlin, Germany, 12683
University Medicine Düsseldorf
Düsseldorf, Germany, 40225
District Hospital Gummersbach
Gummersbach, Germany, 51643
BG Kliniken Bergmannstrost
Halle, Germany, 06112
Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
Hamburg, Germany, 21033
University Medicine Hamburg-Eppendorf
Hamburg, Germany, 220246
Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
Ludwigshafen, Germany, 67071
University Medicine Rostock
Rostock, Germany, 18055
Municipal Clinic Solingen
Solingen, Germany, 42663
Sponsors and Collaborators
University Medicine Greifswald
Deutsche Arthrose-Hilfe
Investigators
Principal Investigator: Andreas Eisenschenk, Prof. Dr. University Medicine Greifswald
  More Information

Responsible Party: Prof. Dr. Andreas Eisenschenk, Prof. Dr., University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01803789     History of Changes
Other Study ID Numbers: 1-2-KiWI
First Submitted: March 1, 2013
First Posted: March 4, 2013
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Dr. Andreas Eisenschenk, University Medicine Greifswald:
Metacarpal V Fractures
Single Kirschner Wires
Double Kirschner Wires

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries