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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthosis group | Active Comparator | 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 | Active Comparator | The patient is instructed to start early rehabilitation about one week after the trauma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasling ER III orthosis | Device | Application of orthosis and start of rehabilitation after four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Union of fracture | recording of fracture union on radiological images | Followed 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford shoulder score | Shoulder specific patient reported outcome measure, PROM, with a maximum score of 48 points | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna C Björnsson Hallgren, MD, PhD | Contact | 0046709473276 | hanna.bjornsson.hallgren@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Lars E Adolfsson, Professor | Linkoeping University | Principal Investigator |
| Hanna C Björnsson Hallgren, MD, PhD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lars Adolfsson | Recruiting | Linköping | 58185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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Parallel assignment
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The assessors are not involved in the treatment and the radiological assessment of images will be assessed with anonymyized images.
| 12 months |
| Quick DASH | Patient reported outcome measure of shoulder function in a 11-item PROM | 12 months |
| Global assessment of improvement | Patient rated assessment of global improvement in a numeric scale with 7 steps | 12 months |
| Shoulder range of motion | The elevation, abduction, internal and external rotation of the injured shoulder | 12 months |