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NCT03596736

Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

Completed NA Last updated 8 March 2023
What this trial tests

NA trial testing Elbow Hemiarthroplasty in Distal Humerus Fracture in 42 participants. Completed in 31 December 2021.

Timeline
19 January 2011
Primary endpoint
30 November 2021
31 December 2021

Quick facts

Lead sponsorLinkoeping University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment42
Start date19 January 2011
Primary completion30 November 2021
Estimated completion31 December 2021
Sites3 locations across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Linkoeping University

Who can join

Eligibility, any sex, with Distal Humerus Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Distal Humerus Fracture

Currently open trials in the same condition.

Other Linkoeping University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03596736.

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