Clinical Trial: Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Return of Function and External Rotation Post Proximal Humerus Fracture Fixation With Neutral Rotation Brace

Brief Summary:

Research question:

Do patients using a neutral rotation brace post surgery have improved functional outcome and external rotation of the shoulder compared to current best practice using a polysling holding the proximal humerus in internal rotation?

Primary objectives:

To compare post-operative functional outcome scores obtained at 6 weeks, 9 weeks, 3 months and 1 year. (Scores at 6 weeks and 3 months in clinical review and postal scores at 9 weeks and 1 year) between patients held in neutral versus current standard rotation. These will be compared to scores taken pre-operatively.

Benefits:

There may be no extra benefits to patients from this trial however the results from the trial will help improve treatment for future patients at this hospital, and others across the country.

Risks/disadvantages:

The operation is the same in both groups studied, the study is investigating the use of the two different slings. The post-operative treatment is also the same, and all patients on the trial will receive the same amount of physiotherapy. It isn't anticipated that there will be any additional risk from this trial.


Detailed Summary:
Sponsor: South Devon Healthcare NHS Foundation Trust

Current Primary Outcome:

  • Oxford score [ Time Frame: 1 Year post surgery ]
    Patients subjective assessment of pain and Activities of Daily Living (ADL) impairment. The Oxford Shoulder Questionnaire has been shown to correlate well with both the Constant Score and the SF36 assessment and to be sensitive to surgical intervention. The Oxford Shoulder Questionnaire accumulates to a total score with a maximum of value of 60, in which four pain related questions make up 33% of this total whilst the remaining 67% is derived from eight ADL related questions. The highest scores are attributed to the worst outcomes in the Oxford Shoulder Questionnaire
  • DASH - the Disabilities of the Arm, Shoulder and Hand [ Time Frame: 1 year post surgery ]
    DASH Scoring system was developed to assess the level of disability for any patient with any condition affecting the upper limb by covering domains including symptoms, physical function and psychological function


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Range of movement(flexion, extension, abduction, external and internal rotation) [ Time Frame: 6 weeks, 3 months and 1 year ]
    Assessed by Physiotherapists. Measurement will be performed using a goniometer to accurately assess range of movement
  • SF-12 Score [ Time Frame: 1 Year post surgery ]
    This survey form has been shown to yield summary physical and mental health outcome scores
  • Range of movement (flexion, extension, abduction and internal rotation) [ Time Frame: 6 weeks, 6 months and 1 year ]
    Conducted by physiotherapists. Measured using a goniometer to accurately assess range of movement
  • Time to union of fracture [ Time Frame: 6 weeks and 3 Months ]
    X-Rays taken
  • Return to work post surgery [ Time Frame: 1 year follow up ]
  • Re-operations and Complications [ Time Frame: Throughout 1st year as applicable at outpatient appointments ]
    Documented at various outpatient appointments


Original Secondary Outcome: Same as current

Information By: South Devon Healthcare NHS Foundation Trust

Dates:
Date Received: February 21, 2014
Date Started: January 2013
Date Completion: December 2015
Last Updated: May 18, 2015
Last Verified: May 2015