Operative Versus Non Operative Treatment of Proximal Humerus (Shoulder Joint) Fractures
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of British Columbia.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of British Columbia
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00818987
First received: January 6, 2009
Last updated: February 17, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
3 and 4 Part Proximal Humerus Fractures |
Other: Open reduction internal fixation; reduction and immobilization |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Operative
Treatment arm - intervention = Open Reduction Internal Fixation or Reduction & Immobilization
|
Other: Open reduction internal fixation; reduction and immobilization |
|
No Intervention: Non Operative
Placebo arm
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Proximal humerus fracture patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818987
Contacts
| Contact: Raman Johal | 604-875-5239 | raman.johal@vch.ca |
Locations
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Raman Johal 604-875-5239 raman.johal@vch.ca | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Pierre Guy, MDCM, MBA, FRCS(C) | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Pierre Guy, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00818987 History of Changes |
| Other Study ID Numbers: | H08-02149 |
| Study First Received: | January 6, 2009 |
| Last Updated: | February 17, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Operative Non operative |
Additional relevant MeSH terms:
|
Fractures, Bone Humeral Fractures Wounds and Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 23, 2013