Clinical trial NCT06360887: Management of Proximal Humerus Fractures in Adults: a Clinical Trial
Official title: Management of Proximal Humerus Fractures in Elderlies: a Clinical Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Fractures
Lead sponsor: Regional Hospital of Bolzano
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults presenting at our hospital with proximal humerus fractures that meet the inclusion and exclusion criteria

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, 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 .

Eligibility criteria: Inclusion Criteria:

1. adults who sustained a Proximal Humerus Fracture within the last week
2. type of Proximal Humerus Fracture AO 11-(A2, A3), 11- (B1, B2, B3)
3. BMI lower than 40 Kg/m2

Exclusion Criteria:

1. stress fractures
2. revision setting
3. open fractures
4. fractures associated with a neurologic lesion; previous fractures or bony procedure at the homolateral side
5. patients unable to understand the procedure or instructions for rehabilitation
6. terminal patients
7. patients presenting multiple injuries

Primary outcomes:
measure: Oxford Shoulder Score
timeFrame: 6, 12, and 24 months after surgery
Secondary outcomes:
measure: The visual analogue scale
timeFrame: 6, 12, and 24 months after surgery
measure: Rate of complications
timeFrame: 6, 12, and 24 months after surgery
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Academic Hospital of Bolzano (SABES-ASDAA)
state: Alto Adige
Study officials:
affiliation: employee
name: Filippo Migliorini, Dr.
role: PRINCIPAL_INVESTIGATOR
References: