Evidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results
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):
- Test the algorithm in terms of clinical applicability and clinical outcome
- 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.
Investigators
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