Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

Study Overview
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Brief Summary
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The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.

Detailed Description
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Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.

Official Title
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Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT

Conditions
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Shoulder Fractures, Humeral Fractures, Proximal

Intervention / Treatment
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* Procedure: Multiloc nail
* Procedure: Philos plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion. Exclusion Criteria: Exclusion criteria: Fracture more than 3 weeks' old Caput humeri just a thin shell or split Ipsilateral damage that will influence the recovery and scoring systems Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. Pathological fracture Neurovascular injury Open fracture Noncompliance Congenital anomaly Ongoing infectious process around the incision site for plate osteosynthesis Systemic disease that may influence healing processes or scoring systems (RA/MS) Fracture dislocation Substance abuse Inability to read and understand Norwegian Patients not residing in our catchment area Patients with too small humerus diameter to use a nail Patient not able to commit and understand written consent

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Philos plate<br>Intervention is surgery with Philos plate | Procedure: Philos plate<br>* Intervention is surgery with Philos plate<br>|
| Active Comparator: Multiloc nail<br>Intervention is surgery with Multiloc nail | Procedure: Multiloc nail<br>* Intervention is surgery with Multiloc nail<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score) | Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score (questionnaire) | A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score) | 5years | 
| Radiological complications | Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence, | 5 years | 
| Complications | Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis | 5 years | 
| Health economy | Registration of visits to doctor, physiotherapist, sick leave, re-operations | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiloc, Philos, Locking plate, Straight nail, Randomized controlled trial, 3 and 4 part fractures