Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

Distal Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596736
• Other study ID #: 2010/342-31
• Status: Completed
• Phase: N/A
• Start date: January 19, 2011
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Humerus Fracture
• Fractures, Bone
• Humeral Fractures

Intervention

Procedure:
• Elbow Hemiarthroplasty

• Total Elbow Arthroplasty

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Linköping University Hospital	Linköping
Sweden	Varberg Hospital	Varberg

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire	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.	24 months