Pegs for Osteofixation of Proximal Humeral Fractures

Study Overview
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Brief Summary
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Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

Detailed Description
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From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events: Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and Avascular head necrosis / sinking / need of re-surgery Clinical PROMS

Official Title
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Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?

Conditions
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Implant Complication, Proximal Humeral Fracture, Avascular Necrosis of Humerus

Intervention / Treatment
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* Device: Open reduction internal fixation (ORIF) with an angular stable plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criterion: Acute proximal humeral fracture AO/OTA type 11-B2 or 11C2 Exclusion Criteria: Not eligible to surgical treatment Non-compliant Former shoulder fracture or symptomatic shoulder illness Drug abuser

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: ALPS-PHP device<br>Patients operated with angular stable plate for displaced PHF with an ALPS plate | Device: Open reduction internal fixation (ORIF) with an angular stable plate<br>* Operative treatment of proximal humeral fracture<br>|
| Group B: Philos device<br>Patients operated with angular stable plate for displaced PHF with a Philos plate | Device: Open reduction internal fixation (ORIF) with an angular stable plate<br>* Operative treatment of proximal humeral fracture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peg penetration into glenohumeral joint | Radiographic or CT verified peg penetration | 12 months | 
| Screw penetration into glenohumeral joint | Radiographic or CT verified screw penetration | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humeral head deformation | Avascular head necrosis or Sinking | 12 months | 
| Shoulder function | Constant-Murley score | 12 months | 
| Self reported shoulder function | Oxford scoulder score | 12 months | 
| Quality of life | Generic 15D score | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humeral head, Screw penetration, Peg penetration, Avascular necrosis