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Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

Primary Purpose

Distal Humerus Fracture

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Elbow Hemiarthroplasty
Total Elbow Arthroplasty
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Humerus Fracture focused on measuring Distal Humerus Fracture, Arthroplasty, Replacement, Elbow

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital
  • Linköping University Hospital
  • Varberg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elbow Hemiarthroplasty

Total Elbow Arthroplasty

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
March 7, 2023
Sponsor
Linkoeping University
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03596736
Brief Title
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures
Official Title
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2011 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Göteborg University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Humerus Fracture
Keywords
Distal Humerus Fracture, Arthroplasty, Replacement, Elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elbow Hemiarthroplasty
Arm Type
Experimental
Arm Title
Total Elbow Arthroplasty
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Elbow Hemiarthroplasty
Intervention Type
Procedure
Intervention Name(s)
Total Elbow Arthroplasty
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Adolfsson, MD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Varberg Hospital
City
Varberg
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

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