Evidence Based Algorithm for Proximal Humerus Fractures

Completed

• Conditions: Proximal Humeral Fracture

• Registration Number: NCT03464578
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Constant Score	One year	Point 0-100

Trial Locations

Locations (1)

Department of Orthopaedic Surgery and Traumatology; 🇨🇭 Saint Gallen, Switzerland