NCT03786679

Brief Summary

Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

5 years

First QC Date

November 5, 2018

Last Update Submit

March 7, 2023

Conditions

Proximal Humeral Fracture

Keywords

Non-operative treatment, orthosis, healing, rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Union of fracture

    recording of fracture union on radiological images

    Followed 12 months

Secondary Outcomes (5)

  • Oxford shoulder score

    12 months

  • Numerical pain reporting scale

    12 months

  • Quick DASH

    12 months

  • Global assessment of improvement

    12 months

  • Shoulder range of motion

    12 months

Study Arms (2)

Orthosis group

ACTIVE COMPARATOR

An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.

Device: Ultrasling ER III orthosis

Early rehabilitation group

ACTIVE COMPARATOR

The patient is instructed to start early rehabilitation about one week after the trauma.

Device: Ultrasling ER III orthosis

Interventions

Ultrasling ER III orthosisDEVICE

Application of orthosis and start of rehabilitation after four weeks.

Early rehabilitation groupOrthosis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A proximal humeral fracture verified on radiology no older than 7-10 days.

You may not qualify if:

  • Surgically treated proximal humeral fracture
  • Fracture only involving the greater tuberosity
  • Previous surgery in the fractured shoulder
  • Ongoing malignancy in the fractured shoulder
  • Neurologic disease
  • Radiating pain from the neck in the affected arm
  • Associated vascular or nerve injuries
  • Dementia
  • Alcohol abuse
  • Unwilling to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lars Adolfsson

Linköping, 58185, Sweden

RECRUITING

Related Publications (1)

  • Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Lars E Adolfsson, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

  • Hanna C Björnsson Hallgren, MD, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna C Björnsson Hallgren, MD, PhD

CONTACT

0046709473276hanna.bjornsson.hallgren@regionostergotland.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2018

First Posted

December 26, 2018

Study Start

February 25, 2019

Primary Completion

February 25, 2024

Study Completion

February 25, 2024

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)