CClinicalTrials.gg
CompletedNCT03596736Updated Mar 8, 2023

Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures

An interventional study of Elbow Hemiarthroplasty and Total Elbow Arthroplasty in Distal Humerus Fracture, sponsored by Linkoeping University. Completed at 3 sites in Sweden. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 5 months after the study started (first participant enrolled Jan 2011, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Distal Humerus Fracture

Keywords

  • Distal Humerus Fracture
  • Arthroplasty, Replacement, Elbow
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 42 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Elbow Hemiarthroplasty

    Procedure: Elbow Hemiarthroplasty

  • Active comparator
    Total Elbow Arthroplasty

    Procedure: Total Elbow Arthroplasty

Interventions

  • ProcedureElbow Hemiarthroplasty
  • ProcedureTotal Elbow Arthroplasty
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

07

Study locations

3 sites
  • Sahlgrenska University Hospital
    Gothenburg, Sweden
  • Linköping University Hospital
    Linköping, Sweden
  • Varberg Hospital
    Varberg, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03596736
Lead sponsor
Linkoeping University
Collaborators
Göteborg University
Responsible party
Lars Adolfsson (Prof, MD, PhD, Linkoeping University) — Principal investigator
First posted
Jul 24, 2018
Start date
Jan 19, 2011
Primary completion
Nov 30, 2021
Completion
Dec 31, 2021
Last update
Mar 8, 2023

Study contacts

Lars Adolfsson, MD
principal investigator · Linkoeping University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion