Management of Proximal Humerus Fractures in Adults: a Clinical Trial

NCT ID: NCT06360887

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 351 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2028-01-31

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 .

Conditions

Shoulder Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Conservative

Participants allocated to conservative management will receive an orthosis (Gilchrist) for a minimum of four weeks. Using Gilchrist, the upper arm of the injured side is secured in abduction and internal rotation with the weight of the arm held by a ring around the patient's neck. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the patient will start a structured program of rehabilitation.

Conservative

Intervention Type: PROCEDURE

Conservative treatment

Open Reduction Internal Fixation

Participants allocated to ORIF will undergo surgery within 72 hours from the diagnosis using a standard deltopectoral approach. An angular stable plate is used in all patients following manufacturer instructions. No drains will be used.

ORIF

Intervention Type: PROCEDURE

Open surgery

Closed Reduction Percutaneous Pinning

Participants allocated to CRPP will be positioned in a beach chair under total anesthesia. The fracture is repositioned under fluoroscopic guidance using manual traction. The osteosynthesis is then done using Kirschner wires.The arm is placed into a Gilchrist for four weeks. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the Kirschner wires will be removed and the patient will start a structured program of rehabilitation.

CRPP

Intervention Type: PROCEDURE

Minimal invasive surgery

Interventions

Conservative

Conservative treatment

Intervention Type: PROCEDURE

ORIF

Open surgery

Intervention Type: PROCEDURE

CRPP

Minimal invasive surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regional Hospital of Bolzano

OTHER

Sponsor Role: lead

Responsible Party

Malte Nikolas Witte

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filippo Migliorini, Dr.

Role: PRINCIPAL_INVESTIGATOR

employee

Locations

Academic Hospital of Bolzano (SABES-ASDAA)

Bolzano, Trentino-Alto Adige, Italy

Countries

Italy

Central Contacts

Malte Nikolas Witte, Dr.

Role: CONTACT

maltewitte@posteo.de

00393885787726

Filippo Migliorini, Dr.

Role: CONTACT

migliorini.md@gmail.com

00393278751794

Facility Contacts

Malte Nikolas Witte, Dr.

Role: primary

maltewitte@posteo.de

00393885787726

Other Identifiers

DRKS00030614

Identifier Type: -

Identifier Source: org_study_id