Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Proximal Humeral Fracture
- Sponsor
- Lars Adolfsson
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Union of fracture
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Lars Adolfsson
Professor
Linkoeping University
Eligibility Criteria
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
- •Alcohol abuse
- •Unwilling to participate in the trial
Outcomes
Primary Outcomes
Union of fracture
Time Frame: Followed 12 months
recording of fracture union on radiological images
Secondary Outcomes
- Quick DASH(12 months)
- Oxford shoulder score(12 months)
- Numerical pain reporting scale(12 months)
- Global assessment of improvement(12 months)
- Shoulder range of motion(12 months)