NCT06360887

Management of Proximal Humerus Fractures in Adults: a Clinical Trial

Management of Proximal Humerus Fractures in Elderlies: a Clinical Trial

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 351 (estimated)
• Sponsor: Regional Hospital of Bolzano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.

Detailed description

The present study shall be conducted in accordance with the SPIRIT 2013 statement: defining standard protocol items for clinical trials. All patients who sustained a PHF and presented at the Department of Orthopedics at the Academic Hospital of Bolzano (Italy) will be prospectively incited to participate in the present clinical trial. Patient recruitment will begin in April 2024, and end in April 2026. The follow-up period will start in October 2024, and end in April 2028. Data analysis will commence in October 2024 and end in April 2028. The present study shall be conducted according to the principles of the Declaration of Helsinki. The authors receive no financial support for the research, authorship, and/or publication of this article. The protocol of the study has been prospectively registered and approved by the German Registry of Clinical Trials (ID DRKS00030614). Ethics approval has been received from the Ethic Committee of the South Tyrolean Health Authority, Bolzano, Italy (ID 2022374 of June 22, 2023). All surgical and conservative procedures under analysis are already routinely carried out at the Department of Orthopaedics and Trauma Surgery of the Academic Hospital of Bolzano, Italy. Patients who meet the inclusion criteria and agree to participate in the study by signing the consent form and the personal data processing form will be included in the study. Data curation Personal data, including sensitive data, will be pseudonymised and associated with a code from which it will be impossible to trace the patient's identity. Only the Principal Investigator and sub-investigators of the study will be able to link the code to the name. The pseudonymised data will be collected in a table of Microsoft Office Excel version 16 (Microsoft Corporation, Redmond, US). Statistical analyses Assuming an actual difference in means between the test and reference group of 3 units and a pooled standard deviation of 5 units, the study would require a sample size of 117 patients for each group (i.e. a total sample size of 351, assuming equal group size), to obtain a power of 80% and a significance level of 5%, to declare the superiority of a technique with a margin of prominence of 5 units, assuming a minimum clinically important difference OSS of 2.7/100 .

Conditions

• Shoulder Fractures

Interventions

Type	Name	Description
PROCEDURE	Conservative	Conservative treatment
PROCEDURE	ORIF	Open surgery
PROCEDURE	CRPP	Minimal invasive surgery

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2024-04-11
• Last updated: 2024-04-12

Locations

1 site across 1 country: Italy