Non-operative Treatment in Sweden of Proximal Humeral Fractures

Not Applicable

Recruiting

• Conditions: Proximal Humeral Fracture
• Interventions: Device: Ultrasling ER III orthosis

• Registration Number: NCT03786679
• Lead Sponsor: Lars Adolfsson

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-12-23
• Study First Posted: 2018-12-26
• Study Start: 2019-02-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2024-02-25
• Study Completion: 2024-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthosis group	Ultrasling ER III orthosis	An orthosis with the broken arm in neutral position fixed for four weeks. After these four weeks the patient is instructed to start rehabilitation.
Early rehabilitation group	Ultrasling ER III orthosis	The patient is instructed to start early rehabilitation about one week after the trauma.

Primary Outcome Measures

Name	Time	Method
Union of fracture	Followed 12 months	recording of fracture union on radiological images

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lars Adolfsson; 🇸🇪 Linköping, Sweden