Clinical Trial: Treatment of Proximal Humerus Fractures in the Elderly

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence

Brief Summary: This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

Detailed Summary: This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: personal dependency status [ Time Frame: 6 months ]

A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • range of motion [ Time Frame: 6 months ]
  • Shoulder pain and disability index (SPADI) [ Time Frame: 6 months ]
    The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available
  • SSV [ Time Frame: 6 months ]
    The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.
  • General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS) [ Time Frame: 6 months ]
    The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.
  • Quality of life (utilities) derived using EQ-5D-5L [ Time Frame: 6 months ]
    Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).


Original Secondary Outcome:

  • range of motion [ Time Frame: 6 months ]
  • SPADI [ Time Frame: 6 months ]
    The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available
  • SSV [ Time Frame: 6 months ]
    The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.
  • General health using EQ-5D-5L VAS [ Time Frame: 6 months ]
    The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.
  • Quality of life (utilities) derived using EQ-5D-5L [ Time Frame: 6 months ]
    Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).


Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: September 30, 2015
Date Started: May 2015
Date Completion: June 2018
Last Updated: January 23, 2017
Last Verified: January 2017