Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures

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

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-10

Study Completion Date

2020-09-02

Brief Summary

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Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.

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Detailed Description

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Conditions

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Humeral Fracture, Proximal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Reverse Total Shoulder Arthroplasty

Group Type EXPERIMENTAL

Reverse Total Shoulder Arthroplasty

Intervention Type PROCEDURE

Hemiarthroplasty

Group Type ACTIVE_COMPARATOR

Hemiarthroplasty

Intervention Type PROCEDURE

Interventions

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Reverse Total Shoulder Arthroplasty

Intervention Type PROCEDURE

Hemiarthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Displaced 3- or 4-part fracture of the proximal humerus
* Age over 70 years
* Independent living
* Low energy trauma

Exclusion Criteria

* Pre-existing shoulder disease
* Severe cognitive dysfunction
* More than 14 days from injury to surgery
* Comorbidity that affects shoulder rehabilitation considerably
* Concurrent injury that affect shoulder rehabilitation considerably

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No