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Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

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ClinicalTrials.gov Identifier: NCT03596736
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Lars Adolfsson, Linkoeping University

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.


Condition or disease Intervention/treatment Phase
Distal Humerus Fracture Procedure: Elbow Hemiarthroplasty Procedure: Total Elbow Arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
Actual Study Start Date : January 19, 2011
Estimated Primary Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elbow Hemiarthroplasty Procedure: Elbow Hemiarthroplasty
Active Comparator: Total Elbow Arthroplasty Procedure: Total Elbow Arthroplasty



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596736


Contacts
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Contact: Lars Adolfsson, MD 0046703361242 Lars.Adolfsson@regionostergotland.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Eythór Jónsson, MD         
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Lars Adolfsson, MD         
Varberg Hospital Recruiting
Varberg, Sweden
Contact: Mikael Etzner         
Sponsors and Collaborators
Linkoeping University
Investigators
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Principal Investigator: Lars Adolfsson, MD Linkoeping University

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Responsible Party: Lars Adolfsson, Prof, MD, PhD, Linkoeping University
ClinicalTrials.gov Identifier: NCT03596736     History of Changes
Other Study ID Numbers: 2010/342-31
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Lars Adolfsson, Linkoeping University:
Distal Humerus Fracture
Arthroplasty, Replacement, Elbow

Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries