Treatment of Proximal Humeral Fractures

Not Applicable

Completed

• Conditions: Humeral Fractures, Proximal
• Interventions: Device: Philos; Other: Control group; Device: Epoca

• Registration Number: NCT01246167
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Study Start: 2011-01
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Philos locking plate	Philos	After operative treatment active physiotherapy and self-training
Conservative	Control group	Active physiotherapy and self-training
Epoca prosthesis	Epoca	After operative treatment active physiotherapy and self-training

Primary Outcome Measures

Name	Time	Method
DASH	2 year	to measure physical function and symptoms of the fractured shoulder

Secondary Outcome Measures

Name	Time	Method
EQ-5D	2 year	Individual's general health related quality of life is measured with EQ-5D

Trial Locations

Locations (6)

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland

Jyväskylä Central Hospital; 🇫🇮 Jyväskylä, Keski-Suomi, Finland

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Regionaalhaigla, PERH; 🇪🇪 Tallinn, Estonia