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

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).

Study Overview

• Status: Completed
• Conditions: Fracture of Metacarpal Bone
• Intervention / Treatment: Device: Single Kirschner Wire; Device: Double Kirschner Wire

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10967
    • Vivantes Hospital Am Urban
  • Berlin, Germany, 10365
    • Sana Clinical Centre Lichtenberg
  • Berlin, Germany, 12683
    • Trauma Hospital Berlin
  • Düsseldorf, Germany, 40225
    • University Medicine Düsseldorf
  • Gummersbach, Germany, 51643
    • District Hospital Gummersbach
  • Halle, Germany, 06112
    • BG Kliniken Bergmannstrost
  • Hamburg, Germany, 21033
    • Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
  • Hamburg, Germany, 220246
    • University Medicine Hamburg-Eppendorf
  • Ludwigshafen, Germany, 67071
    • Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
  • Rostock, Germany, 18055
    • University Medicine Rostock
  • Solingen, Germany, 42663
    • Municipal Clinic Solingen
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
      • University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score	6 months after randomisation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Deutsche Arthrose-Hilfe
• Investigators: Principal Investigator: Andreas Eisenschenk, Prof. Dr., University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Metacarpal V Fractures; Single Kirschner Wires; Double Kirschner Wires
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 1-2-KiWI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No