Costal Fracture Assessment for Relief and Enhancement of Quality of Life

NCT ID: NCT06405841

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 950 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-01-31

Brief Summary

This study explores the impact of rib fractures on patient well-being and quality of life, aiming to identify effective interventions for pain relief and functional improvement. It investigates the long-term outcomes of conservative treatment for rib fractures, analyzing factors such as analgesic therapy, hospitalization duration, and respiratory infection rates. Anticipated results include a comprehensive assessment of patient quality of life and the potential translational implications for healthcare practice. Furthermore, the study aims to inform healthcare resource optimization, potentially guiding treatment decisions and improving patient outcomes within the National Health Service.

Detailed Description

Thoracic trauma remains a significant cause of morbidity and mortality in the traumatized population. Rib fractures are the most commonly encountered injuries after thoracic trauma, accounting for approximately 10-15% of all trauma-related hospital admissions. Fractured ribs serve as surrogate indicators of severe injuries, as most patients suffer additional critical injuries. Rib fractures are associated with significant long-term morbidity and disability, resulting in enduring physical impairment, dyspnea, and delayed return to normal daily and work activities, leading to decreased quality of life. Additionally, previous studies have demonstrated that up to a quarter of patients with rib fractures experience persistent chest pain even one year or more after the trauma. In current clinical practice, surgical treatment of rib fractures is increasingly common, as restoring chest wall integrity appears to alleviate pain and preserve normal breathing mechanics. While recent studies suggest that rib fracture fixation may improve lung function, reduce (pulmonary) complication rates, and shorten hospitalization and intensive care unit (ICU) stays in selected patients, a definitive consensus on which patients should undergo surgery has yet to be established. Contributing to the difficulty in determining optimal treatment for patients with rib fractures is the limited research on long-term quality of life and functional outcomes after rib fracture fixation or conservative management. Therefore, this study aims to investigate the quality of life of patients with rib fractures treated conservatively using a dedicated questionnaire and evaluate the type of analgesic medical therapy used, length of hospital stay, and rate of respiratory infections.

Expected Results, Translatability, and Impact on the National Health Service (SSN):

Expected Results: It is anticipated that the study will provide a detailed assessment of the quality of life of patients with rib fractures treated conservatively and their long-term quality of life. Additionally, the study aims to identify the most effective types of analgesic medical therapies in controlling rib fracture-related pain, as well as the duration of hospitalization and rate of respiratory infections associated with conservative treatment.

Translatability: The study results could have broad practical applications in the healthcare sector, providing guidance on best practices for rib fracture treatment. This could lead to greater efficacy in rib fracture management protocols, reducing or increasing the need for surgical interventions to improve patient quality of life.

Impact on the National Health Service (SSN): The study could have a significant impact on the SSN by providing evidence to optimize healthcare resources through more targeted management of rib fractures. If the results demonstrate that conservative treatment is ineffective for certain types of rib fractures, as it entails a longer hospital stay with very late return to daily and work activities, these patients could be selected for surgical treatment, resulting in savings for the SSN and an improvement in patient quality of life.

Conditions

Rib Fractures; Rib Trauma

Study Design

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

Study Groups

Patients with rib fractures

Patients with rib fractures that correspond to inclusion and exclusion criteria

Survey

Intervention Type: OTHER

All patients will be asked to complete a survey at 1, 2, 4, 12 and 24 weeks from the trauma to assess their quality of life

Pain management

Intervention Type: OTHER

All patients will be asked about their pain management at 1, 2, 4, 12 and 24 weeks from the trauma to assess if they are under medication and what kind of medication are they taking

Interventions

Survey

All patients will be asked to complete a survey at 1, 2, 4, 12 and 24 weeks from the trauma to assess their quality of life

Intervention Type: OTHER

Pain management

All patients will be asked about their pain management at 1, 2, 4, 12 and 24 weeks from the trauma to assess if they are under medication and what kind of medication are they taking

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with rib fractures

Exclusion Criteria

• cognitive impairment
• chronic pain due to pathologic fractures
• active cancer

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

Sponsors

Ospedali Riuniti Trieste

OTHER

Sponsor Role: lead

Responsible Party

Manuela Mastronardi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emergency Department

Trieste, Italy, Italy

Intensive Care Unit

Trieste, Italy, Italy

Department of General Surgery

Trieste, TS, Italy

Department of Thoracic Surgery

Trieste, TS, Italy

Countries

Italy

Central Contacts

Alan Biloslavo, MD

Role: CONTACT

alan.biloslavo@asugi.sanita.fvg.it

+390403994152

Facility Contacts

Entiola Celaj

Role: primary

Laura Giordano

Role: backup

Sabina Gerebizza

Role: primary

Lucia Comuzzi

Role: backup

Manuela Mastronardi, MD

Role: primary

manuela.mastronardi@gmail.com

0403994152 ext. 0039

Alan Biloslavo, MD

Role: backup

Paola Germani, MD

Role: backup

Nicolò de Manzini, MD

Role: backup

Manuela Mastronardi, MD

Role: backup

Marina Troian, MD

Role: primary

Stefano Lovadina

Role: backup

Marina Troian

Role: backup

References

Mastronardi M, Troian M, Germani P, Lovadina S, de Manzini N, Celaj E, Biloslavo A. Costal fracture assessment for relief and enhancement of quality of life-CARE study. Eur J Trauma Emerg Surg. 2025 Jan 9;51(1):3. doi: 10.1007/s00068-024-02689-3.

Reference Type: DERIVED

PMID: 39786597 (View on PubMed)

Other Identifiers

345_2024H

Identifier Type: -

Identifier Source: org_study_id