NCT Number: NCT03596736
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Sahlgrenska University Hospital, Gothenburg, Sweden
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Total Elbow Arthroplasty
ProcedurePrimary 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.
Sponsors and collaborators
Lead sponsor
Linkoeping University
Other Gov
Collaborators
- Göteborg University
Registry information
Official study title
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
Important dates
- Study start
- 2011
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Jul 24, 2018
- Registry last updated
- Mar 8, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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