Evidence Based Algorithm for Proximal Humerus Fractures

Proximal Humeral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464578
• Other study ID #: ProxHumFx
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Procedure:
• Therapy of proximal humeral fractures (irrespective conservative or operative)

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedic Surgery and Traumatology	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Score	Point 0-100	One year