Non-operative Treatment in Sweden of Proximal Humeral Fractures

Study Overview
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Brief Summary
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Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.

Official Title
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Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.

Conditions
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Proximal Humeral Fracture

Intervention / Treatment
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* Device: Ultrasling ER III orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A proximal humeral fracture verified on radiology no older than 7-10 days. Exclusion Criteria: Surgically treated proximal humeral fracture Fracture only involving the greater tuberosity Previous surgery in the fractured shoulder Ongoing malignancy in the fractured shoulder Neurologic disease Radiating pain from the neck in the affected arm Associated vascular or nerve injuries Dementia Alcohol abuse Unwilling to participate in the trial

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
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orthosis group<br>An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation. | Device: Ultrasling ER III orthosis<br>* Application of orthosis and start of rehabilitation after four weeks.<br>|
| Active Comparator: Early rehabilitation group<br>The patient is instructed to start early rehabilitation about one week after the trauma. | Device: Ultrasling ER III orthosis<br>* Application of orthosis and start of rehabilitation after four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union of fracture | recording of fracture union on radiological images | Followed 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford shoulder score | Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points | 12 months | 
| Numerical pain reporting scale | Patient reported outcome measure of pain at rest, at night and during activity in scales with 10 steps grading subjective assessment of pain | 12 months | 
| Quick DASH | Patient reported outcome measure of shoulder function in a 11-item PROM | 12 months | 
| Global assessment of improvement | Patient rated assessment of global improvement in a numeric scale with 7 steps | 12 months | 
| Shoulder range of motion | The elevation, abduction, internal and external rotation of the injured shoulder | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-operative treatment, orthosis, healing, rehabilitation