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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Procedure: Therapy of proximal humeral fractures (irrespective conservative or operative)

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• Switzerland
  • Saint Gallen, Switzerland, 9007
    • Department of Orthopaedic Surgery and Traumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with an acute proximal humeral fracture admitted to our institution.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Score	Point 0-100	One year

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Study Director: Bernhard Jost, MD, Head of the departement

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: ProxHumFx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No