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Trials / Completed

CompletedNCT03596736

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
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Linkoeping University · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREElbow Hemiarthroplasty
PROCEDURETotal Elbow Arthroplasty

Timeline

Start date
2011-01-19
Primary completion
2021-11-30
Completion
2021-12-31
First posted
2018-07-24
Last updated
2023-03-08

Locations

3 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03596736. Inclusion in this directory is not an endorsement.

Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures (NCT03596736) · Clinical Trials Directory