NCT06405841

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

May 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

May 4, 2024

Last Update Submit

November 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ability to achieve daily living activities (yes/no)

    the ability to achieve daily living activities will be measured using a specific survey

    1, 2, 4, 12 and 24 weeks from the trauma

Secondary Outcomes (3)

  • Pain killers assumption

    1, 2, 4, 12 and 24 weeks from the trauma

  • Respiratory infection rate

    1, 2, 4, 12 and 24 weeks from the trauma

  • Lenght of stay

    to 2 years after the trauma

Study Arms (1)

Patients with rib fractures

Patients with rib fractures that correspond to inclusion and exclusion criteria

Other: SurveyOther: Pain management

Interventions

SurveyOTHER

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

Patients with rib fractures

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

Patients with rib fractures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with rib fractures matching inclusion and exclusion criteria will be involved in the study

You may qualify if:

  • Patients with rib fractures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emergency Department

Trieste, Italy, 34149, Italy

Location

Intensive Care Unit

Trieste, Italy, 34149, Italy

Location

Department of General Surgery

Trieste, TS, 34149, Italy

Location

Department of Thoracic Surgery

Trieste, TS, 34149, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Rib Fractures

Interventions

Surveys and QuestionnairesPain Management

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTherapeuticsDisease ManagementPatient Care ManagementHealth Services Administration

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 9, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations