Management of Proximal Humerus Fractures in Adults: a Clinical Trial

Management of Proximal Humerus Fractures in Elderlies: a Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Fractures
• Intervention / Treatment: Procedure: Conservative; Procedure: ORIF; Procedure: CRPP

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 .

• Study Type: Observational
• Enrollment (Estimated): 351

Contacts and Locations

• Study Contact: Name: Malte Nikolas Witte, Dr.; Phone Number: 00393885787726; Email: maltewitte@posteo.de
• Study Contact Backup: Name: Filippo Migliorini, Dr.; Phone Number: 00393278751794; Email: migliorini.md@gmail.com

Study Locations

• Italy
  • Alto Adige
    • Bolzano, Alto Adige, Italy, 39100
      • Academic Hospital of Bolzano (SABES-ASDAA)
      • Contact: Malte Nikolas Witte, Dr.; Phone Number: 00393885787726; Email: maltewitte@posteo.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults presenting at our hospital with proximal humerus fractures that meet the inclusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Conservative; 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.	Procedure: ORIF; 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.	Procedure: CRPP; Minimal invasive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of complications	persistent pain, frozen shoulder, malunion, surgery, nerve damage	6, 12, and 24 months after surgery

Collaborators and Investigators

• Sponsor: Regional Hospital of Bolzano
• Investigators: Principal Investigator: Filippo Migliorini, Dr., Employee

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: DRKS00030614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: when data is publicised
• IPD Sharing Access Criteria: information will be shared if asked for with other researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No