Humeral Fractures, Proximal
Conditions
Keywords
Proximal humerus fracture, conservative, locking plate, Philos, Hemiprosthesis
Brief 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.
Interventions
DEVICEPhilos
Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.
DEVICEEpoca
Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
OTHERControl group
Conservative control group
Sponsors
Kuopio University Hospital
Jyväskylä Central Hospital
Karolinska University Hospital
Tampere University
Academy of Finland
Uppsala University Hospital
Aarhus University Hospital
Regionaalhaigla, Tallinn
Tartu University Hospital
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DASH | 6 months | to measure physical function and symptoms of the fractured shoulder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 6 month | Individual's general health related quality of life is measured with EQ-5D |
Countries
Denmark, Estonia, Finland, Sweden
Outcome results
None listed