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NCT03786679: NOSWEPH

Non-operative Treatment in Sweden of Proximal Humeral Fractures

Status unknown NA Last updated 8 March 2023
What this trial tests

NA trial testing Ultrasling ER III orthosis in Proximal Humeral Fracture in 400 participants. Status unknown.

Timeline
25 February 2019
Primary endpoint
25 February 2024
25 February 2024

Quick facts

Lead sponsorLars Adolfsson
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment400
Start date25 February 2019
Primary completion25 February 2024
Estimated completion25 February 2024
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Lars Adolfsson

Who can join

18 and older, any sex, with Proximal Humeral Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Interventions for treating proximal humeral fractures in adults.
    Handoll HH, Elliott J, Thillemann TM, Aluko P, et al · · 2022 · cited 79× · PMID 35727196 · DOI 10.1002/14651858.cd000434.pub5
  2. The Benefits and Harms of Early Mobilization and Supervised Exercise Therapy after Non-surgically Treated Proximal Humerus or Distal Radius fracture: A systematic Review and Meta-analysis.
    Østergaard HK, Mechlenburg I, Launonen AP, Vestermark MT, et al · · 2021 · cited 17× · PMID 33689149 · DOI 10.1007/s12178-021-09697-5
  3. Immobilization Period for the Non-Operative Treatment of Proximal Humerus Fractures: Systematic Review and Meta-Analysis.
    Ataei M, Moradi A, Ebrahimzadeh MH, Rastaghi S, et al · · 2024 · cited 1× · PMID 38716180 · DOI 10.22038/abjs.2023.76126.3519

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Other recruiting trials for Proximal Humeral Fracture

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Data sources for this page

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