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

University Hospital Basel logo

University Hospital Basel

Status

Active, not recruiting

Conditions

Nonunion of Fracture
Rib Fractures

Study type

Observational

Funder types

Other

Identifiers

NCT06788067
2024-02144 kt25Lardinois;

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Delayed SSRF
Description:
Patients who underwent surgery between 3 weeks and 3 months after trauma
Nonunion SSRF
Description:
Patients who underwent surgery more than 3 months after trauma

Trial contacts and locations

1

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Central trial contact

Didier Lardinois, Prof.; Maria Svec

Data sourced from clinicaltrials.gov

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