Trials / Completed
CompletedNCT03596736
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Linkoeping University · Other Government
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Elbow Hemiarthroplasty | |
| PROCEDURE | Total Elbow Arthroplasty |
Timeline
- Start date
- 2011-01-19
- Primary completion
- 2021-11-30
- Completion
- 2021-12-31
- First posted
- 2018-07-24
- Last updated
- 2023-03-08
Locations
3 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03596736. Inclusion in this directory is not an endorsement.