Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?

Study Overview
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Brief Summary
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To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.

Detailed Description
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Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder prosthesis. Angular stable plate means Proximal humerus plate (Philos)

Official Title
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Clinical Investigation for Fractures of the Proximal Humerus in Elderly Patients. A Randomized Study of Two Surgical Treatments: Reverse Total Shoulder Arthroplasty Versus Angular Stable Device Philos

Conditions
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Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2

Intervention / Treatment
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* Device: Reverse total shoulder arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient admitted in hospital with a displaced three- or four part proximal humerus fracture of OTA / AO group 11-B2 or 11-C2 (displaced fracture of extra-articular or articular, bifocal type). The subgroups -.1, -.2 and -.3 will be included for both B2 and C2 groups, provided severe displacement: This is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. The greater or lesser tubercle displaced at least 10 mm. Exclusion Criteria: Patient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. Patients have to understand the Norwegian language and be compliant to rehabilitation and follow-ups.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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: Angular stable plate Philos<br>Open Reduction and Osteofixation with Philos plate and TiCron cerclages | Device: Reverse total shoulder arthroplasty<br> <br> * Other names: Delta Xtend shoulder proshesis;|
| Experimental: Reverse Total Shoulder Artroplasty<br>Intervention group | Device: Reverse total shoulder arthroplasty<br> <br> * Other names: Delta Xtend shoulder proshesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Shoulder Score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Shoulder score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reversed prosthesis, Philos, Severe displaced