Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

February 17, 2021 updated by: Lars Adolfsson, Linkoeping University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Linköping, Sweden
        • Linkoping University Hospital
      • Varberg, Sweden
        • Varberg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elbow Hemiarthroplasty
Procedure: Elbow Hemiarthroplasty
Active Comparator: Total Elbow Arthroplasty
Procedure: Total Elbow Arthroplasty

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Göteborg University

Investigators

  • Principal Investigator: Lars Adolfsson, MD, Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2011

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/342-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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