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Clinical Trials/NCT03786679
NCT03786679
Recruiting
Not Applicable

Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.

Lars Adolfsson1 site in 1 country400 target enrollmentFebruary 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Humeral Fracture
Sponsor
Lars Adolfsson
Enrollment
400
Locations
1
Primary Endpoint
Union of fracture
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2019
End Date
February 25, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lars Adolfsson
Responsible Party
Sponsor Investigator
Principal Investigator

Lars Adolfsson

Professor

Linkoeping University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
  • Alcohol abuse
  • Unwilling to participate in the trial

Outcomes

Primary Outcomes

Union of fracture

Time Frame: Followed 12 months

recording of fracture union on radiological images

Secondary Outcomes

  • Quick DASH(12 months)
  • Oxford shoulder score(12 months)
  • Numerical pain reporting scale(12 months)
  • Global assessment of improvement(12 months)
  • Shoulder range of motion(12 months)

Study Sites (1)

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