Proximal Humeral Fracture
Conditions
Keywords
Non-operative treatment, orthosis, healing, rehabilitation
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.
Interventions
DEVICEUltrasling ER III orthosis
Application of orthosis and start of rehabilitation after four weeks.
Sponsors
Lars Adolfsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Union of fracture | Followed 12 months | recording of fracture union on radiological images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Quick DASH | 12 months | Patient reported outcome measure of shoulder function in a 11-item PROM |
| 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 |
Countries
Sweden
Contacts
Primary ContactHanna C Björnsson Hallgren, MD, PhD
Outcome results
None listed