Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal 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

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-19

Study Completion Date

2021-12-31

Brief Summary

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Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. In elderly patients, poor bone quality (osteopenia) and fragmentation of the articular surface can make rigid internal fixation non-reliable or even impossible. Total elbow arthroplasty has been shown to be of value in this type of situation. Elbow hemiarthroplasty has been proposed as an alternative to total elbow arthroplasty. The theoretical advantages as opposed to total elbow arthroplasty are: no restriction in the weight allowed to be lifted, complications related to polyethylene wear debris are avoided as there is no polyethylene liner and there is no ulna component that can loosen. Wear of the native ulna and instability are potential complications of elbow hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that elbow hemiarthroplasty gives better elbow function than total elbow arthroplasty for irreparable distal humeral fractures.

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Detailed Description

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Conditions

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Distal Humerus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Elbow Hemiarthroplasty

Group Type EXPERIMENTAL

Elbow Hemiarthroplasty

Intervention Type PROCEDURE

Total Elbow Arthroplasty

Group Type ACTIVE_COMPARATOR

Total Elbow Arthroplasty

Intervention Type PROCEDURE

Interventions

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Elbow Hemiarthroplasty

Intervention Type PROCEDURE

Total Elbow Arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Intra-articular distal humeral fracture with two or more displaced joint surface fragments devoid of soft tissue attachment
* Osteopenia
* Fracture deemed unsuitable for internal fixation
* Low-energy trauma
* Closed fracture
* Independent living

Exclusion Criteria

* Comorbidity that affects elbow rehabilitation considerably
* Severe pre-existing elbow disease
* Concurrent injury that affects elbow rehabilitation considerably
* Pathologic fracture
* Vascular injury
* Inability to participate in follow-up

Eligible Sex

ALL

Accepts Healthy Volunteers

No