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Clinical Trials/NCT03596736
NCT03596736
Completed
Not Applicable

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

Linkoeping University3 sites in 1 country42 target enrollmentStarted: January 19, 2011Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Linkoeping University
Enrollment
42
Locations
3
Primary Endpoint
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Linkoeping University
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Lars Adolfsson

Prof, MD, PhD

Linkoeping University

Study Sites (3)

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