Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nonunion of Fracture; Rib Fractures

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Department of Thoracic Surgery, University Hospital Basel

Participation Criteria

Eligibility Criteria

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

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Delayed SSRF; Patients who underwent surgery between 3 weeks and 3 months after trauma
Nonunion SSRF; Patients who underwent surgery more than 3 months after trauma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain status at Follow-up (FU)	The pain status at the timepoint of the follow-up visit is measured using the numeric rating scale (NRS, scale 0: no pain to 10: worst pain) in different situations (at rest, at movement, and during deep inspiration). The type of pain (local, diffuse, neurogenic) will be also assessed.	After surgery at follow-up visit (1-8 weeks after recruitment)
Recommendation of the surgery to another person in a situation like the own	The patients will be asked if they would recommend the surgery to another person in a situation like the own. The assessment will be performed in two categories: yes/no.	After surgery at follow-up visit (1-8 weeks after recruitment)
Pain status at FU compared to before surgery	The pain status at the timepoint of the follow-up visit compared to the timepoint before surgery in five distinct categories on a Likert-scale (much better, slightly better, no change, slightly worse, much worse).	After surgery at follow-up visit (1-8 weeks after recruitment)
Painkiller Use (including nonsteroidal anti-inflammatory drugs and opioids)	The painkiller use including nonsteroidal anti-inflammatory drugs and opioids is being recorded.	After surgery at follow-up visit (1-8 weeks after recruitment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health status	The subjective health-related quality of life is recorded using the 12-Item Short-Form (SF-12) questionnaire. The SF-12 is a validated scale used to assess physical and mental health, with scores ranging from 0 to 100, where higher scores indicate better health and well-being.	After surgery at follow-up visit (1-8 weeks after recruitment)
Resumption of daily/professional activity at FU	Resumption of former professional activity and daily activities will be assessed by use of the numeric rating scale (NRS, scale 0: no pain to 10: worst pain).	After surgery at follow-up visit (1-8 weeks after recruitment)
Resumption of daily/professional activity at FU compared to before surgery	Resumption of former professional activity and daily activities will be assessed by comparison with the situation before trauma and before surgery (much better, slightly better, no change, slightly worse, much worse).	After surgery at follow-up visit (1-8 weeks after recruitment)
Complications	Complications related to surgery until/at 30 d after surgery according to the Clavien-Dindo classification.	Day 30 after surgery
Correlation between Number of Broken Ribs, Fixed Ribs, and Impact on Patient Outcomes	This outcome assesses the relationship between the number of broken ribs, the number of surgically fixed ribs, and their influence on patient recovery and clinical outcomes.	After surgery at follow-up visit (1-8 weeks after recruitment)
Frequency of Risk Factors for Rib Fracture Nonunion	Frequency of risk factors for nonunion like nicotine use, diabetes mellitus, medication use including nonsteroidal anti-inflammatory drugs and opioids, osteoporosis, hypothyroidism.	After surgery at follow-up visit (1-8 weeks after recruitment)
Physical examination	The incidence of chest wall instability and persistent clicking is assessed at the FU visit by a physical examination.	After surgery at follow-up visit (1-8 weeks after recruitment)
Association between Age and clinical outcomes	This outcome measures the association between patient age and the clinical outcomes following rib fractures.	After surgery at follow-up visit (1-8 weeks after recruitment)
Impact of Gender and Clinical Outcomes	This outcome measures the impact of patient's gender and clinical outcomes following rib fractures	After surgery at follow-up visit (1-8 weeks after recruitment)
Impact of Rib Fracture Localization on Clinical Outcomes	This outcome measures the impact of the location of rib fractures on clinical outcomes.	After surgery at follow-up visit (1-8 weeks after recruitment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the decision for surgery	Satisfaction with the decision for surgery will be assessed by use of NRS (numerical rating scale). (Would you have let the surgery done again? 0=Yes, absolutely satisfied; 10= absolutely dissatisfied):	After surgery at follow-up visit (1-8 weeks after recruitment)
Satisfaction with cosmetic results	Satisfaction with cosmetic results of the surgery will be assessed with numeric rating scale (NRS: 0= absolutely satisfied; 10= absolutely dissatisfied)	After surgery at follow-up visit (1-8 weeks after recruitment)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Maria Svec, Department of Thoracic Surgery, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): August 4, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Surgical stabilization of rib fractures (SSRF); Delayed SSRF; Nonunion SSRF
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Fractures, Ununited; Rib Fractures
• Other Study ID Numbers: 2024-02144; kt25Lardinois

Drug and device information, study documents

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