Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

Study Overview
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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.

Official Title
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Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial

Conditions
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Distal Humerus Fracture

Intervention / Treatment
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* Procedure: Elbow Hemiarthroplasty
* Procedure: Total Elbow Arthroplasty


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elbow Hemiarthroplasty<br> | Procedure: Elbow Hemiarthroplasty<br> <br> |
| Active Comparator: Total Elbow Arthroplasty<br> | Procedure: Total Elbow Arthroplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire | The DASH questionnaire aims to assess symptoms and functional status of the upper extremities. It is a patient reported outcome measure that contains 30 core items. The score ranges from 0 to 100 points with higher scores indicating greater impairment. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Humerus Fracture, Arthroplasty, Replacement, Elbow