Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT06788067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: