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Non-operative Treatment in Sweden of Proximal Humeral Fractures

NCT03786679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-03-08

No results posted yet for this study

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.

Conditions

  • Proximal Humeral Fracture

Interventions

DEVICE

Ultrasling ER III orthosis

Application of orthosis and start of rehabilitation after four weeks.

Sponsors & Collaborators

  • Lars Adolfsson

    lead OTHER_GOV

Principal Investigators

  • Lars E Adolfsson, Professor · Linkoeping University

  • Hanna C Björnsson Hallgren, MD, PhD · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2024-02-25
Completion
2024-02-25

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03786679 on ClinicalTrials.gov