Actively Recruiting

Phase Not Applicable
Age: 60Years - 85Years
All Genders
Healthy Volunteers
NCT04106674

Two- Part Proximal Humerus - Conservative vs Operative

Led by University Hospital, Akershus · Updated on 2022-10-25

50

Participants Needed

1

Research Sites

734 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?

CONDITIONS

Official Title

Two- Part Proximal Humerus - Conservative vs Operative

Who Can Participate

Age: 60Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 60 years and under 85 years
  • Displaced two-part proximal humeral fracture meeting specific displacement or angulation criteria
  • Tuberculum majus or minor fractures displaced less than 5mm but meeting above criteria
  • Patients admitted to Akershus University Hospital requiring surgical treatment
  • Patients able to provide consent and participate in follow-up
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Fracture older than 3 weeks
  • No contact between head and shaft of the humerus
  • Ipsilateral injury affecting recovery or scoring
  • Incapable of protecting osteosynthesis due to other injuries
  • Pathological or previous fracture of the same proximal humerus
  • Multitrauma or multiple fractures
  • Neurovascular injury
  • Open fracture
  • Noncompliance, dementia, or institutionalization
  • Congenital anomalies
  • Active infection near surgical site
  • Systemic diseases affecting healing (e.g., rheumatoid arthritis, multiple sclerosis, poorly controlled diabetes)
  • Fracture dislocation
  • Substance abuse
  • Inability to read and understand Norwegian
  • Not residing in the hospital's catchment area
  • Humerus diameter too small for nailing
  • Medical conditions excluding surgery, including high ASA score or considered too ill for surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Akershus University Hospital

Lørenskog, Oslo, Norway, 0587

Actively Recruiting

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Research Team

A

Annette Konstanse Bordewich Wikerøy, MD

CONTACT

H

Hendrik Fuglesang, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Two- Part Proximal Humerus - Conservative vs Operative | DecenTrialz