Non-operative Treatment in Sweden of Proximal Humeral Fractures (NOSWEPH)

Lars Adolfsson

Status: Enrolling

Conditions: Proximal Humeral Fracture

Treatments: Device: Ultrasling ER III orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03786679

06000836

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Orthosis group

Active Comparator group

Description:

An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.

Treatment:

Device: Ultrasling ER III orthosis

Early rehabilitation group

Active Comparator group

Description:

The patient is instructed to start early rehabilitation about one week after the trauma.

Treatment:

Device: Ultrasling ER III orthosis