Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03596736

Enrollment

Registered

2018-07-24

Start date

2011-01-19

Completion date

2021-12-31

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Humerus Fracture

Keywords

Distal Humerus Fracture, Arthroplasty, Replacement, Elbow

Brief summary

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.

Interventions

PROCEDUREElbow Hemiarthroplasty

PROCEDURETotal Elbow Arthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire	24 months	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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026