Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

• Sponsor: Linkoeping University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03596736
• Collaborator: Göteborg University (Other)
• Enrollment: 42
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 131.4
• Patients Per Site: 14
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Humerus Fracture	Procedure: Elbow Hemiarthroplasty; Procedure: Total Elbow Arthroplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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: Jan 19, 2011
• Anticipated Primary Completion Date: Nov 30, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden
2	Linköping University Hospital	Linköping		Sweden
3	Varberg Hospital	Varberg		Sweden

Sponsors and Collaborators

• Linkoeping University
• Göteborg University

Investigators

• Principal Investigator: Lars Adolfsson, MD, Linkoeping University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars Adolfsson, Prof, MD, PhD, Linkoeping University
• ClinicalTrials.gov Identifier: NCT03596736
• Other Study ID Numbers: 2010/342-31
• First Posted: Jul 24, 2018
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Lars Adolfsson, Prof, MD, PhD, Linkoeping University: Distal Humerus Fracture; Arthroplasty, Replacement, Elbow
• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures

Study Results

No Results Posted as of Feb 21, 2021