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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00818987
Enrollment
120
Registered
2009-01-08
Start date
2010-11-30
Completion date
2011-10-31
Last updated
2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3 and 4 Part Proximal Humerus Fractures

Keywords

Operative, Non operative

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.

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.

Interventions

OTHEROpen reduction internal fixation; reduction and immobilization

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Proximal humerus fracture patients

Design outcomes

Primary

MeasureTime frame
Primary outcome measurement will be the patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire1 year

Secondary

MeasureTime frame
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 independence1 year

Countries

Canada

Contacts

Primary ContactRaman Johal
raman.johal@vch.ca604-875-5239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026