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

University of British Columbia

Status and phase: Unknown; Phase 1

Conditions: 3 and 4 Part Proximal Humerus Fractures

Treatments: Other: Open reduction internal fixation; reduction and immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT00818987

H08-02149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Proximal humerus fracture patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Operative

Other group

Description:

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

Treatment:

Other: Open reduction internal fixation; reduction and immobilization

Non Operative

No Intervention group

Description:

Placebo arm