Evidence Based Algorithm for Proximal Humerus Fractures
NCT ID: NCT03464578
Last Updated: 2021-08-16
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
143 participants
OBSERVATIONAL
2014-01-01
2020-12-31
Brief Summary
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Objective(s):
1. Test the algorithm in terms of clinical applicability and clinical outcome
2. Compare general outcome and general complication/revision rate to the literature.
Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded.
Terminally ill patients and those not being able, or willing to sing the informed consent.
Project Centre(s): Single-centre.
Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05.
Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Therapy of proximal humeral fractures (irrespective conservative or operative)
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Multilevel fractures of the humerus
* Pathological fractures
* Terminally ill patients.
ALL
No
Sponsors
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Cantonal Hospital of St. Gallen
OTHER
Responsible Party
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Bernhard Jost
Prof. Dr. med, Head of Departement
Principal Investigators
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Bernhard Jost, MD
Role: STUDY_DIRECTOR
Head of the departement
Locations
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Department of Orthopaedic Surgery and Traumatology
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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ProxHumFx
Identifier Type: -
Identifier Source: org_study_id
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