Clinical Trial: Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

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

Official Title: Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus

Brief Summary:

  1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
  2. Do surgical treatment gain more QALY than conservative treatment after one year?

Detailed Summary:
Sponsor: University Hospital, Aker

Current Primary Outcome: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). [ Time Frame: 12 and 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • QALY (HRQoL score according to Harri Sintonen 15D and Costs) [ Time Frame: 12 and 24 months ]
  • ASES score (modified self assessment) C) Radiographic score [ Time Frame: 12 and 24 months ]
  • Radiographic score [ Time Frame: 12 and 24 months ]


Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: March 16, 2009
Date Started: May 2003
Date Completion:
Last Updated: April 22, 2015
Last Verified: April 2015