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Clinical Trials/NCT03464578
NCT03464578
Completed
Not Applicable

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

Cantonal Hospital of St. Gallen1 site in 1 country143 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Humeral Fracture
Sponsor
Cantonal Hospital of St. Gallen
Enrollment
143
Locations
1
Primary Endpoint
Constant Score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bernhard Jost

Prof. Dr. med, Head of Departement

Cantonal Hospital of St. Gallen

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Constant Score

Time Frame: One year

Point 0-100

Study Sites (1)

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