Recruiting
Phase 1

Operative vs. Non Operative

Sponsor:

University of British Columbia

Code:

NCT00818987

Conditions

3 and 4 Part Proximal Humerus Fractures

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Open reduction internal fixation; reduction and immobilization

Study Details

Brief 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.

Conditions

3 and 4 Part Proximal Humerus Fractures

Study ID

NCT00818987

Start date

Nov, 2010

Status verified date

Feb, 2011

Completion date

Oct, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Proximal humerus fracture patients

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Operative

Treatment arm - intervention = Open Reduction Internal Fixation or Reduction \& Immobilization

no intervention: Non Operative

Placebo arm

Interventions

Open reduction internal fixation; reduction and immobilization

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Raman Johal

604-875-5239raman.johal@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Raman Johal

604-875-5239raman.johal@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

Feb 21, 2011

Last verified

Feb, 2011

Keywords

  • Operative
  • Non operative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2011-02-21.