Clinical Trial: Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial

Brief Summary: A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.

Detailed Summary:
Sponsor: Oslo University Hospital

Current Primary Outcome: Quick-DASH [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]

Validated hand function score


Original Primary Outcome: Quick-DASH [ Time Frame: 1 year after primary treatment ]

Validated hand function score


Current Secondary Outcome:

  • Patient satisfaction [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]
    VAS scale
  • Pain [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]
    VAS scale
  • Eq-5d [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]
    Validated quality of life score
  • Complications [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]
    All complications are noted
  • Sick-leave [ Time Frame: 1 week, 6 weeks, 3 months (1 year, 2 years) ]
    Days of sick-leave off work
  • Range of motion in the joints in the 5th finger measured by hand therapist [ Time Frame: 3 months, 1 year, 2 years ]
    total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
  • Grip strength [ Time Frame: 3 months, 1 year, 2 years ]
    Compared to the non-injured hand
  • Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand [ Time Frame: 6 weeks, 1 year ]


Original Secondary Outcome:

  • Patient satisfaction [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]
    VAS scale
  • Pain [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]
    VAS scale
  • Eq-5d [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ]
    Validated quality of life score
  • Complications [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ]
    All complications are noted
  • Sick-leave [ Time Frame: 1 week, 6 weeks, 3 months (1 year, 2 years) ]
    Days of sick-leave off work
  • Range of motion in the joints in the 5th finger measured by hand therapist [ Time Frame: 3 months, 1 year, 2 years ]
    total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
  • Grip strength [ Time Frame: 3 months, 1 year, 2 years ]
    Compared to the non-injured hand
  • Angular displacement in fracture measured in lateral x-ray of the 5th ray of the hand [ Time Frame: 6 weeks, 1 year ]


Information By: Oslo University Hospital

Dates:
Date Received: May 18, 2010
Date Started: May 2010
Date Completion:
Last Updated: April 23, 2015
Last Verified: April 2015