Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

Not Applicable

Completed

• Conditions: Distal Humerus Fracture
• Interventions: Procedure: Elbow Hemiarthroplasty; Procedure: Total Elbow Arthroplasty

• Registration Number: NCT03596736
• Lead Sponsor: Linkoeping University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-19
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elbow Hemiarthroplasty	Elbow Hemiarthroplasty	-
Total Elbow Arthroplasty	Total Elbow Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Varberg Hospital; 🇸🇪 Varberg, Sweden