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| Name | Class |
|---|---|
| Sykehuset Telemark | OTHER_GOV |
| Sykehuset Asker og Baerum | OTHER |
| Sykehuset Ostfold | OTHER |
| Helse Forde |
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To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.
Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder prosthesis.
Angular stable plate means Proximal humerus plate (Philos)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angular stable plate Philos | Active Comparator | Open Reduction and Osteofixation with Philos plate and TiCron cerclages |
|
| Reverse Total Shoulder Artroplasty | Experimental | Intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reverse total shoulder arthroplasty | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant Shoulder Score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 15D Quality of Life score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years |
| Health Economics | Follow-up will be at 3-6-12 months and 2-5 years. |
Inclusion Criteria:
Patient admitted in hospital with a displaced three- or four part proximal humerus fracture of OTA / AO group 11-B2 or 11-C2 (displaced fracture of extra-articular or articular, bifocal type). The subgroups -.1, -.2 and -.3 will be included for both B2 and C2 groups, provided severe displacement: This is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. The greater or lesser tubercle displaced at least 10 mm.
Exclusion Criteria:
Patient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. Patients have to understand the Norwegian language and be compliant to rehabilitation and follow-ups.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25261913 | Result | Fjalestad T, Iversen P, Hole MO, Smedsrud M, Madsen JE. Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos (The DELPHI-trial). BMC Musculoskelet Disord. 2014 Sep 28;15:323. doi: 10.1186/1471-2474-15-323. | |
| 31977825 |
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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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| OTHER |
| Sykehuset i Vestfold HF | OTHER |
| Diakonhjemmet Hospital | OTHER |
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| 5 years |
| Fraser AN, Bjordal J, Wagle TM, Karlberg AC, Lien OA, Eilertsen L, Mader K, Apold H, Larsen LB, Madsen JE, Fjalestad T. Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Mar 18;102(6):477-485. doi: 10.2106/JBJS.19.01071. |
| 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. |
| 35109905 | Derived | Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3. |