Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360887
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-28
Brief Title:
Management of Proximal Humerus Fractures in Adults a Clinical Trial
Sponsor:
Regional Hospital of Bolzano
Organization:
Regional Hospital of Bolzano
Study Overview
Official Title:
Management of Proximal Humerus Fractures in Elderlies a Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 patients 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 ie 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 27100
Data curation Personal data including sensitive data will be pseudonymised and associated with a code from which it will be impossible to trace the patients 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 ie 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 27100
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None