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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Medicine Greifswald
Sponsor:
Collaborator:
Registered Association for German Arthrosis Help (Deutsche Arthrose Hilfe e.V.)
Information provided by (Responsible Party):
Prof. Dr. Andreas Eisenschenk, University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01803789
First received: March 1, 2013
Last updated: June 4, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 randomistaion ]
  • 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 ]

Estimated Enrollment: 320
Study Start Date: May 2013
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803789

Contacts
Contact: Andreas Eisenschenk, Prof. Dr. +493834866101 andreas.eisenschenk@uni-greifswald.de
Contact: Romy Spitzmüller +493834866125 romy.spitzmueller@uni-greifswald.de

Locations
Germany
University Medicine Greifswald Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Contact: Andreas Eisenschenk, Prof. Dr.         
Principal Investigator: Andreas Eisenschenk, Prof. Dr.         
Trauma Hospital Berlin Recruiting
Berlin, Germany, 12683
Contact: Adrian Obladen         
Sub-Investigator: Adrian Obladen         
Sana Clinical Centre Lichtenberg Recruiting
Berlin, Germany, 10365
Contact: Hartmut Schauer, Dr.         
Principal Investigator: Hartmut Schauer, Dr.         
Vivantes Hospital Am Urban Recruiting
Berlin, Germany, 10967
Contact: Mohssen Hakimi, Priv.-Doz. Dr.         
Principal Investigator: Mohssen Hakimi, Priv.-Doz. Dr.         
University Medicine Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Joachim Windolf, Prof. Dr.         
Principal Investigator: Joachim Windolf, Prof. Dr.         
District Hospital Gummersbach Recruiting
Gummersbach, Germany, 51643
Contact: Walter Schäfer, Dr.         
Principal Investigator: Walter Schäfer, Dr.         
BG Kliniken Bergmannstrost Not yet recruiting
Halle, Germany, 06112
Contact: Frank Siemers, PD. Dr.         
Principal Investigator: Frank Siemers, PD Dr.         
Berufsgenossenschaftliches Unfallkrankenhaus Hamburg Recruiting
Hamburg, Germany, 21033
Contact: Klaus-Dieter Rudolf, Dr.         
Principal Investigator: Klaus-Dieter Rudolf, Dr.         
University Medicine Hamburg-Eppendorf Recruiting
Hamburg, Germany, 220246
Contact: Johannes Rüger, Prof. Dr.         
Principal Investigator: Johannes Rüger, Prof. Dr.         
Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen Recruiting
Ludwigshafen, Germany, 67071
Contact: Berthold Bickert, Dr.         
Principal Investigator: Berthold Bickert, Dr.         
University Medicine Münster Not yet recruiting
Münster, Germany, 48129
Contact: Martin Langer, Priv.-Doz. Dr.         
Principal Investigator: Martin Langer, Priv.-Doz. Dr.         
University Medicine Rostock Recruiting
Rostock, Germany, 18055
Contact: Alice Wichelhaus, Dr.         
Principal Investigator: Alice Wichelhaus, Dr.         
Municipal Clinic Solingen Recruiting
Solingen, Germany, 42663
Contact: Christian Voigt, Prof. Dr.         
Principal Investigator: Christian Voigt, Prof. Dr.         
Sponsors and Collaborators
University Medicine Greifswald
Registered Association for German Arthrosis Help (Deutsche Arthrose Hilfe e.V.)
Investigators
Principal Investigator: Andreas Eisenschenk, Prof. Dr. University Medicine Greifswald
  More Information

No publications provided

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
Study First Received: March 1, 2013
Last Updated: June 4, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Medicine Greifswald:
Metacarpal V Fractures
Single Kirschner Wires
Double Kirschner Wires

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014