Completed

Evidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Shoulder Injuries+1

+ Shoulder Fractures

+ Wounds and Injuries

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2014
See protocol details

Summary

Principal SponsorCantonal Hospital of St. Gallen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures. 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.

Official TitleEvidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results
NCT03464578
Principal SponsorCantonal Hospital of St. Gallen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

143 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Shoulder InjuriesShoulder FracturesWounds and InjuriesFractures, Bone

Criteria

2 inclusion criteria required to participate
Acute traumatic proximal humeral fracture

Signed informed consent

4 exclusion criteria prevent from participating
Fracture older than 48 hours at admission

Multilevel fractures of the humerus

Pathological fractures

Terminally ill patients.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Orthopaedic Surgery and Traumatology

Sankt Gallen, SwitzerlandOpen Department of Orthopaedic Surgery and Traumatology in Google Maps
CompletedOne Study Center