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Evidence Based Algorithm for Proximal Humerus Fractures

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03464578
Enrollment
143
Registered
2018-03-14
Start date
2014-01-01
Completion date
2020-12-31
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fracture

Brief summary

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.

Interventions

PROCEDURETherapy of proximal humeral fractures (irrespective conservative or operative)

Sponsors

Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Acute traumatic proximal humeral fracture * Signed informed consent

Exclusion criteria

* Fracture older than 48 hours at admission * Multilevel fractures of the humerus * Pathological fractures * Terminally ill patients.

Design outcomes

Primary

MeasureTime frameDescription
Constant ScoreOne yearPoint 0-100

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026