Management of Proximal Humerus Fractures in Adults: a Clinical Trial

Shoulder Fractures Clinical Trial

Official title:

Management of Proximal Humerus Fractures in Elderlies: a Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360887
• Other study ID #: DRKS00030614
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: April 2024
• Source: Regional Hospital of Bolzano
• Contact: Malte Nikolas Witte, Dr.
• Phone: 00393885787726
• Email: maltewitte[@]posteo.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 351
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Conservative
Conservative treatment
• ORIF
Open surgery
• CRPP
Minimal invasive surgery

Locations

Country	Name	City	State
Italy	Academic Hospital of Bolzano (SABES-ASDAA)	Bolzano	Alto Adige

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital of Bolzano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Shoulder Score	The primary endpoint of interest will be the Oxford Shoulder Score. The Oxford Shoulder Score is a patient-reported outcome measure developed to evaluate perceived pain and quality of life in subjects who received a shoulder operation. It can be used independently from the performed surgical treatment, excluding only surgical stabilisations. As the Italian province of Bolzano is bilingual (Italian and German), the Italian and German versions of the Oxford Shoulder Score shall be administered. Both versions of the Oxford Shoulder Score are valid and reliable, with high internal consistency and reproducibility. The Oxford Shoulder Score comprises 12 items with five possible answers each: pain (four items) and quality of life (eight items).; The Oxford Shoulder Score contains two subscales, pain (20 points) and activities of daily living (40 points). Scores range from 0 to 60, with a higher score being consistent with increased disability.	6, 12, and 24 months after surgery
Secondary	The visual analogue scale	The visual analogue scale (VAS) is a scale used to determine the pain intensity. The minimum value is 0, the maximum value is 10, with 0 meaning no pain and 10 the worst pain imaginable.	6, 12, and 24 months after surgery
Secondary	Rate of complications	persistent pain, frozen shoulder, malunion, surgery, nerve damage	6, 12, and 24 months after surgery