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

Primary Purpose

Fracture of Metacarpal Bone

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Single Kirschner Wire
Double Kirschner Wire
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Metacarpal Bone focused on measuring Metacarpal V Fractures, Single Kirschner Wires, Double Kirschner Wires

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medicine Greifswald
  • Sana Clinical Centre Lichtenberg
  • Vivantes Hospital Am Urban
  • Trauma Hospital Berlin
  • University Medicine Düsseldorf
  • District Hospital Gummersbach
  • BG Kliniken Bergmannstrost
  • Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
  • University Medicine Hamburg-Eppendorf
  • Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
  • University Medicine Rostock
  • Municipal Clinic Solingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single Kirschner Wire

Double Kirschner Wire

Arm Description

Antegrade intramedullary fixation of with a single Kirschner wire.

Antegrade intramedullary fixation with double Kirschner wire.

Outcomes

Primary Outcome Measures

Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2013
Last Updated
November 2, 2017
Sponsor
University Medicine Greifswald
Collaborators
Deutsche Arthrose-Hilfe
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1. Study Identification

Unique Protocol Identification Number
NCT01803789
Brief Title
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
Acronym
1-2-KiWI
Official Title
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medicine Greifswald
Collaborators
Deutsche Arthrose-Hilfe

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Metacarpal Bone
Keywords
Metacarpal V Fractures, Single Kirschner Wires, Double Kirschner Wires

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Kirschner Wire
Arm Type
Active Comparator
Arm Description
Antegrade intramedullary fixation of with a single Kirschner wire.
Arm Title
Double Kirschner Wire
Arm Type
Active Comparator
Arm Description
Antegrade intramedullary fixation with double Kirschner wire.
Intervention Type
Device
Intervention Name(s)
Single Kirschner Wire
Intervention Type
Device
Intervention Name(s)
Double Kirschner Wire
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Malposition or angulation in the frontal and sagittal planes of max. 5°
Time Frame
6 months after randomisation
Title
Shortening of the metacarpus >2mm
Time Frame
6 months after randomisation
Title
Palmar angulation >30°
Time Frame
6 months after randomisation
Title
Non-union/Pseudarthrosis
Time Frame
6 months after randomisation
Title
Limitation of fist closure
Time Frame
6 months after randomisation
Title
Flexion or extension lag
Time Frame
6 months after randomisation
Title
Pain intensity <10 points (VAS)
Time Frame
6 months after randomisation
Title
Duration of surgical intervention
Time Frame
6 months after randomisation
Title
Rate of re-interventions
Time Frame
6 months after randomisation
Title
Rate of infections
Time Frame
6 months after randomisation
Title
Rate of perforation/dislocation/break of the fracture fixation devices
Time Frame
6 months after randomisation
Title
Duration of inability to work
Time Frame
6 months after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Eisenschenk, Prof. Dr.
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medicine Greifswald
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17489
Country
Germany
Facility Name
Sana Clinical Centre Lichtenberg
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Vivantes Hospital Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Trauma Hospital Berlin
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
University Medicine Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
District Hospital Gummersbach
City
Gummersbach
ZIP/Postal Code
51643
Country
Germany
Facility Name
BG Kliniken Bergmannstrost
City
Halle
ZIP/Postal Code
06112
Country
Germany
Facility Name
Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
City
Hamburg
ZIP/Postal Code
21033
Country
Germany
Facility Name
University Medicine Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
220246
Country
Germany
Facility Name
Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67071
Country
Germany
Facility Name
University Medicine Rostock
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Facility Name
Municipal Clinic Solingen
City
Solingen
ZIP/Postal Code
42663
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures

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