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The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.
Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Philos plate | Active Comparator | Intervention is surgery with Philos plate |
|
| Multiloc nail | Active Comparator | Intervention is surgery with Multiloc nail |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiloc nail | Procedure | Intervention is surgery with Multiloc nail |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score) | Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Constant score (questionnaire) | A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score) | 5years |
| Radiological complications |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asbjorn AAroen, PhD MD | Akershus University Hospital, orthopedic unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University hospital | Lørenskog | 1478 | Norway |
| 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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De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 28, 2026 | |
| Reset | May 19, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2026 | May 19, 2026 |
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| Philos plate |
| Procedure |
Intervention is surgery with Philos plate |
|
Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,
| 5 years |
| Complications | Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis | 5 years |
| Health economy | Registration of visits to doctor, physiotherapist, sick leave, re-operations | 5 years |