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Completed

NCT Number: NCT01803789

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

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).

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Key information

Conditions

Fracture of Metacarpal Bone

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Kirschner Wire

Device

Double Kirschner Wire

Device

Primary outcomes

  1. 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 outcomes

  1. Malposition or angulation in the frontal and sagittal planes of max. 5°

    Time frame: 6 months after randomisation

  2. Shortening of the metacarpus >2mm

    Time frame: 6 months after randomisation

  3. Palmar angulation >30°

    Time frame: 6 months after randomisation

  4. Non-union/Pseudarthrosis

    Time frame: 6 months after randomisation

  5. Limitation of fist closure

    Time frame: 6 months after randomisation

  6. Flexion or extension lag

    Time frame: 6 months after randomisation

  7. Pain intensity <10 points (VAS)

    Time frame: 6 months after randomisation

  8. Duration of surgical intervention

    Time frame: 6 months after randomisation

  9. Rate of re-interventions

    Time frame: 6 months after randomisation

  10. Rate of infections

    Time frame: 6 months after randomisation

  11. Rate of perforation/dislocation/break of the fracture fixation devices

    Time frame: 6 months after randomisation

  12. Duration of inability to work

    Time frame: 6 months after randomisation

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Deutsche Arthrose-Hilfe

Registry information

Acronym: 1-2-KiWI

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2013
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.