Clinical trial NCT06788067: Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
Official title: Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rib Fractures
Nonunion of Fracture
Keywords: Surgical stabilization of rib fractures (SSRF)
Delayed SSRF
Nonunion SSRF
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 75-80, patients who underwent rib fixation later than 3 weeks after trauma at the Department of Thoracic Surgery of the University Hospital Basel between 2012 and end of June 2024

Brief summary: The goal of this monocentric observational study is to evaluate the outcomes of patients who underwent a delayed surgical stabilization of rib fractures/surgical stabilization of rib fracture nonunion (SSRFN) based on the timing of surgery after trauma.

Detailed description: Rib fractures occur in a significant number of patients with blunt chest trauma, and while conservative treatment remains the standard, surgical stabilization of rib fractures (SSRF) has shown improved clinical outcomes. However, conservative therapy often results in chronic chest pain and long-term incapacity, with up to 64% of patients experiencing persistent pain. Additionally, rib fracture nonunion, a condition where the bone fails to heal, affects approximately 12-15% of cases treated conservatively and can lead to long-term complications, including pain, limited mobility, and impaired quality of life.

This single-center observational study aims to analyze the outcomes of patients who underwent delayed SSRF (surgery between 3 weeks and 3 months after trauma) or nonunion SSRF (surgery performed more than 3 months after trauma). To assess whether a shorter interval between trauma and surgery results in better outcomes, the primary objective is to assess the persistence of thoracic pain in both patient groups. The secondary objective is to determine if SSRF improved patients' well-being.

This prospective research project is a single center analysis of existing data on patients, who underwent rib fixation for nonunion at the Department of Thoracic Surgery of the University Hospital Basel between January 1st, 2012 and June 30th, 2024. A prospective follow-up visit will be organized to assess the postoperative outcome.

The results of this study will provide valuable insights into optimizing treatment timelines for non consolidated rib fractures or rib fracture nonunion, improving patient outcomes and reducing long-term pain and disability.

Eligibility criteria: Inclusion Criteria:

* Patients who signed the study specific consent form
* Patients aged ≥18 years at the time of informed consent
* Patients who provided written informed consent in accordance with ICH-GCP regulations prior to participating any protocol-specific follow-up
* Patients with at least one rib fracture caused by trauma (traffic accident, falls), surgery (cardiac, thoracic, lung transplantation), sports, cough, and cardiopulmonary resuscitation

Exclusion Criteria:

* Patients who were treated conservatively
* Patients who underwent rib fixation till 3 weeks after trauma
* Patients who underwent SSRF prior to SSRFN
* Patients who are unable to follow the procedures of the study, e. g. have insufficient knowledge of German or French languages, psychological disorders, dementia etc.
* Patients with a pathological rib fracture(s) due to malignancy or radiation
* Participation in any interventional study in our department that might influence any of the outcome parameters
* Patients who underwent an initial surgery of rib fracture prior to development of a rib fracture nonunion

Primary outcomes:
measure: Pain status at Follow-up (FU)
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Recommendation of the surgery to another person in a situation like the own
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Pain status at FU compared to before surgery
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Painkiller Use (including nonsteroidal anti-inflammatory drugs and opioids)
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
Secondary outcomes:
measure: Health status
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Resumption of daily/professional activity at FU
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Resumption of daily/professional activity at FU compared to before surgery
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Complications
timeFrame: Day 30 after surgery
measure: Correlation between Number of Broken Ribs, Fixed Ribs, and Impact on Patient Outcomes
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Association between Age and clinical outcomes
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Impact of Gender and Clinical Outcomes
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Impact of Rib Fracture Localization on Clinical Outcomes
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Frequency of Risk Factors for Rib Fracture Nonunion
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Physical examination
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
Other outcomes:
measure: Satisfaction with the decision for surgery
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
measure: Satisfaction with cosmetic results
timeFrame: After surgery at follow-up visit (1-8 weeks after recruitment)
Locations:
city: Basel
country: Switzerland
facility: Department of Thoracic Surgery, University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: Department of Thoracic Surgery, University Hospital Basel
name: Maria Svec
role: PRINCIPAL_INVESTIGATOR
References: