Treatment of Proximal Humeral Fractures

Tampere University Hospital250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

250

Conditions

Humeral Fractures, Proximal

Interventions

Eligibility

Sex: ALLMin age: 60 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 2 part fracture where fracture line emerges through the surgical (or anatomical) neck * Low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture Exclusion Criteria: * Refuse to participate the study * Less than 60 years old * Non-independent * Dementia and/or institutionalized * Does no understand written and spoken guidance in either Finnish or Swedish * Pathological fracture or previous fracture in the same proximal humerus * Serious intoxicant dependent, eg. In first aid breathalyzer shows more than 2‰ * Other operational injury in the same upper limb * Major nerve injury (eg. Complete radialis- or delta palsy) * Open fracture * Multi-trauma or -fractured patient * Fracture dislocation or head splitting fracture * Undisplaced fracture * Isolated tuberculum fracture * Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface) * Treating surgeon considers patient unsuitable to attend the study on medical basis * Cuff-arthropathy

Locations (6)

Aarhus University Hospital

Aarhus, Denmark

Regionaalhaigla, PERH

Tallinn, Estonia

Jyväskylä Central Hospital

Jyväskylä, Central Finland, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Karolinska University Hospital

Stockholm, Sweden

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

DASH

to measure physical function and symptoms of the fractured shoulder

Time frame: 6 months

DASH

to measure physical function and symptoms of the fractured shoulder

Time frame: 1 year

DASH

to measure physical function and symptoms of the fractured shoulder

Time frame: 2 year

Secondary Outcomes

EQ-5D

Individual's general health related quality of life is measured with EQ-5D

Time frame: 6 month

EQ-5D

Individual's general health related quality of life is measured with EQ-5D

Time frame: 1 year

EQ-5D

Individual's general health related quality of life is measured with EQ-5D

Time frame: 2 year