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Two- Part Proximal Humerus - Conservative vs Operative

NCT04106674 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-10-25

No results posted yet for this study

Summary

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

  • Proximal Humerus Fracture
  • 2 Part Fracture

Interventions

PROCEDURE

Open reduction internal stabilisation (ORIF)

Treatment allocated to surgical or non-surgical group. Implant choice pragmatic, surgeons choice.

Sponsors & Collaborators

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Asbjørn Aarøen, Professor · Akershus Universitetssykehus HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-10-01
Completion
2034-10-31

Countries

  • Norway

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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 NCT04106674 on ClinicalTrials.gov