NCT03464578

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. 1.Test the algorithm in terms of clinical applicability and clinical outcome
  2. 2.Compare general outcome and general complication/revision rate to the literature.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

7 years

First QC Date

March 1, 2018

Last Update Submit

August 13, 2021

Conditions

Proximal Humeral Fracture

Outcome Measures

Primary Outcomes (1)

  • Constant Score

    Point 0-100

    One year

Interventions

Therapy of proximal humeral fractures (irrespective conservative or operative)PROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Acute traumatic proximal humeral fracture
  • Signed informed consent

You may not qualify if:

  • Fracture older than 48 hours at admission
  • Multilevel fractures of the humerus
  • Pathological fractures
  • Terminally ill patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery and Traumatology

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Bernhard Jost, MD

    Head of the departement

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med, Head of Departement

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 14, 2018

Study Start

January 1, 2014

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)