Treatment of Proximal Humeral Fractures

Study Overview
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Brief Summary
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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.

Official Title
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An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients

Conditions
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Humeral Fractures, Proximal

Intervention / Treatment
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* Device: Philos
* Device: Epoca
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative<br>Active physiotherapy and self-training | Other: Control group<br>* Conservative control group<br>|
| Active Comparator: Philos locking plate<br>After operative treatment active physiotherapy and self-training | Device: Philos<br>* Conservative treatment versus Philos locking plate in 2 part fracture group. Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.<br>|
| Active Comparator: Epoca prosthesis<br>After operative treatment active physiotherapy and self-training | Device: Epoca<br>* Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH | to measure physical function and symptoms of the fractured shoulder | 6 months | 
| DASH | to measure physical function and symptoms of the fractured shoulder | 1 year | 
| DASH | to measure physical function and symptoms of the fractured shoulder | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | Individual's general health related quality of life is measured with EQ-5D | 6 month | 
| EQ-5D | Individual's general health related quality of life is measured with EQ-5D | 1 year | 
| EQ-5D | Individual's general health related quality of life is measured with EQ-5D | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal humerus fracture, conservative, locking plate, Philos, Hemiprosthesis