Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures
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|ClinicalTrials.gov Identifier: NCT03596736|
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Distal Humerus Fracture||Procedure: Elbow Hemiarthroplasty Procedure: Total Elbow Arthroplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial|
|Actual Study Start Date :||January 19, 2011|
|Estimated Primary Completion Date :||June 30, 2021|
|Experimental: Elbow Hemiarthroplasty||
Procedure: Elbow Hemiarthroplasty
|Active Comparator: Total Elbow Arthroplasty||
Procedure: Total Elbow Arthroplasty
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596736
|Contact: Lars Adolfsson, MD||0046703361242||Lars.Adolfsson@regionostergotland.se|
|Sahlgrenska University Hospital||Recruiting|
|Contact: Eythór Jónsson, MD|
|Linköping University Hospital||Recruiting|
|Contact: Lars Adolfsson, MD|
|Contact: Mikael Etzner|
|Principal Investigator:||Lars Adolfsson, MD||Linkoeping University|