Non-operative Treatment in Sweden of Proximal Humeral Fractures

Proximal Humeral Fracture Clinical Trial

— NOSWEPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786679
• Other study ID #: 06000836
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: February 25, 2024

Study information

• Verified date: March 2023
• Source: Linkoeping University
• Contact: Hanna C Björnsson Hallgren, MD, PhD
• Phone: 0046709473276
• Email: hanna.bjornsson.hallgren[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 25, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Device:
• Ultrasling ER III orthosis
Application of orthosis and start of rehabilitation after four weeks.

Locations

Country	Name	City	State
Sweden	Lars Adolfsson	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Lars Adolfsson

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union of fracture	recording of fracture union on radiological images	Followed 12 months
Secondary	Oxford shoulder score	Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points	12 months
Secondary	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
Secondary	Quick DASH	Patient reported outcome measure of shoulder function in a 11-item PROM	12 months
Secondary	Global assessment of improvement	Patient rated assessment of global improvement in a numeric scale with 7 steps	12 months
Secondary	Shoulder range of motion	The elevation, abduction, internal and external rotation of the injured shoulder	12 months