Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures

3 and 4 Part Proximal Humerus Fractures Clinical Trial

Official title:

A Multicentre Prospective Randomized Control Trial on the Treatment of Three and Four Part Proximal Humerus Fractures in Patients 70 Years and Older: Comparing Open Reduction and Internal Fixation With Non Operative Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00818987
• Other study ID #: H08-02149
• Status: Recruiting
• Phase: Phase 1
• First received: January 6, 2009
• Last updated: February 17, 2011
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2011
• Source: University of British Columbia
• Contact: Raman Johal
• Phone: 604-875-5239
• Email: raman.johal[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To determine if operative treatment of non operative management of these fractures is best. Hypothesis: There is no difference in functional outcome between operative and non-operatively treated 3- and 4-part proximal humerus fractures at one year's time.

Description:

Participants of 70 years of age or older who have been medically assessed as 'fit for surgery' are randomly (like flipping a coin) to either operative or non operative management of their injury. Clinical follow-up including x-rays, and physical assessment of injured shoulder, and outcomes questionnaires will be used to determine which if either resulted in the best outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Proximal humerus fracture patients

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 3 and 4 Part Proximal Humerus Fractures
• Fractures, Bone
• Humeral Fractures

Intervention

Other:
• Open reduction internal fixation; reduction and immobilization

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire		1 year	No
Secondary	Functional and mental status instruments (i.e. SF-36/EQ-5D) used to assess the patient's health-related quality of life;, re-operation rates; and the time required to return to pre-injury level of independence		1 year	No