Clinical Trials Directory

Trials / Completed

CompletedNCT03464578

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
Phase
Study type
Observational
Enrollment
143 (actual)
Sponsor
Cantonal Hospital of St. Gallen · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETherapy of proximal humeral fractures (irrespective conservative or operative)

Timeline

Start date
2014-01-01
Primary completion
2020-12-31
Completion
2020-12-31
First posted
2018-03-14
Last updated
2021-08-16

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03464578. Inclusion in this directory is not an endorsement.