Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
38 participants
OBSERVATIONAL
2017-07-01
2021-08-01
Brief Summary
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Detailed Description
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1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
2. Avascular head necrosis / sinking / need of re-surgery
3. Clinical PROMS
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A: ALPS-PHP device
Patients operated with angular stable plate for displaced PHF with an ALPS plate
Open reduction internal fixation (ORIF) with an angular stable plate
Operative treatment of proximal humeral fracture
Group B: Philos device
Patients operated with angular stable plate for displaced PHF with a Philos plate
Open reduction internal fixation (ORIF) with an angular stable plate
Operative treatment of proximal humeral fracture
Interventions
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Open reduction internal fixation (ORIF) with an angular stable plate
Operative treatment of proximal humeral fracture
Eligibility Criteria
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Inclusion Criteria
* AO/OTA type 11-B2 or 11C2
Exclusion Criteria
* Non-compliant
* Former shoulder fracture or symptomatic shoulder illness
* Drug abuser
55 Years
90 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Tore Fjalestad
MD. PhD. Senior Consultant Ortophaedic Surgeon
Principal Investigators
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Tore Fjalestad, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital, Ortophaedic Dept.
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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2017/681
Identifier Type: -
Identifier Source: org_study_id
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