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

NCT ID: NCT00818987

Last Updated: 2011-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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3 and 4 Part Proximal Humerus Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative

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

Group Type OTHER

Open reduction internal fixation; reduction and immobilization

Intervention Type OTHER

Non Operative

Placebo arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Open reduction internal fixation; reduction and immobilization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Proximal humerus fracture patients
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Pierre Guy, MDCM, MBA, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Raman Johal

Role: CONTACT

604-875-5239

Facility Contacts

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Raman Johal

Role: primary

604-875-5239

References

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Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Reference Type DERIVED
PMID: 35727196 (View on PubMed)

Other Identifiers

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H08-02149

Identifier Type: -

Identifier Source: org_study_id

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