Department of Thoracic Surgery, University Hospital Basel
Basel, 4031, Switzerland
NCT Number: NCT06003595
The main study objective is to evaluate the long-term outcome in a prospective follow-up visit of patients who underwent hardware removal after surgical stabilization of rib fractures (SSRF) after a blunt chest trauma .
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Notify Me18 year and older
All sexes
Observational
Basel, 4031, Switzerland
Potential of surgical stabilization of rib fractures (SSRF) to improve clinical outcomes in patients has been demonstrated with increasing interest of surgeons in this procedure and indications for SSRF expanding. Some reports found signals for hardware removal after SSRF such as hardware failure, infections and persisting pain. There is currently lack of studies collecting systematically long-term outcomes after SSRF hardware removal. For that reason, this project presents the retrospective case series of patients with removal of osteosynthetic material after rib stabilisation treated at Department of Thoracic Surgery of the University Hospital Basel (USB). The recovery of these patients will be reviewed and a prospective evaluation of long-term outcomes will be done. The aim is to provide an insight and implications for treatment strategies of future patients. Most of the collected patient data are retrospective data. One prospective follow-up visit inclusive a health survey per patient will be performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey.
Time frame: One time assessment at baseline (prospective Follow up-visit)
The questions are formulated as an adapted question set of the EQ-5D-5L Dimension (EQ-5D-5L) questionnaire followed by additional study specific questions. A numerical rating scale (NRS) will be used for evaluation from 0 - 10. In addition, the patient will be asked to rate the condition now compared to before hardware removal in four categories (less good, no change, slightly better, much better). The analysis of the project data will be done descriptive.
Time frame: Up to 3 years until prospective Follow up-visit
Number of removed hardware and affected ribs (retrospective analyses)
Time frame: Up to 3 years until prospective Follow up-visit
Number of broken and fixed ribs with used hardware (retrospective analyses)
Time frame: Up to 3 years until prospective Follow up-visit
Interval between SSRF and hardware removal (retrospective analyses)
Time frame: Up to 3 years until prospective Follow up-visit
Interval between SSRF and follow-up visit (retrospective analyses)
Time frame: Up to 3 years until prospective Follow up-visit
Occurrence of significant complications during and 30 days after SSRF hardware removal (retrospective analyses)
Time frame: Up to 3 years until prospective Follow up-visit
Surgical indication for hardware removal
University Hospital, Basel, Switzerland
Other
Acronym: REMOVE
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