Treatment of Proximal Humeral Fractures

Summary

This trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. A cost-effectiveness analysis and comparison between different treatment modalities will be carried out. The primary outcome measure will be the DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years and follow-up 2 years.

Conditions

• Humeral Fractures, Proximal

Interventions

DEVICE

Philos

Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.

DEVICE

Epoca

Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group

OTHER

Control group

Conservative control group

Sponsors & Collaborators

• Kuopio University Hospital

  collaborator OTHER

• Jyväskylä Central Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Tampere University

  collaborator OTHER

• Academy of Finland

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Regionaalhaigla, Tallinn

  collaborator UNKNOWN

• Tartu University Hospital

  collaborator OTHER

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Minna Laitinen, Docent · Tampere University Hospital

• Antti Launonen, MD · Tampere University Hospital

• Pekka Rissanen, Professor · Tampere University

• Johanna Ojanperä, MD · Kuopio University Hospital

• Vesa Lepola, MD, PhD · Tampere University Hospital

• Timo Viljakka, MD · Tampere University Hospital

• Ville M Mattila, Professor · Tampere University Hospital

• Juha Paloneva, MD PhD · Jyväskylä Central Hospital

• Hans Berg, Docent · Karolinska University Hospital

• Karl-Åke Jansson, Docent · Karolinska University Hospital

• Kjeld Soballe, Professor · Aarhus University Hospital

• Kaj Dossing, MD · Central Jutland Regional Hospital

• Helle Ostergaard, Msc · Central Jutland Regional Hospital

• Inger Mechlenburg, PhD · University of Aarhus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2019-11-30

Completion

2019-11-30

Countries

• Denmark
• Estonia
• Finland
• Sweden

Study Locations