Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma

Rib Fractures Clinical Trial

— REMOVE  

Official title:

Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003595
• Other study ID #: 2023-01191; kt23Lardinois3
• Status: Completed
• Start date: August 4, 2023
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient treated at the Department of Thoracic Surgery, USB for implantation and removal of rib fixation hardware

• Blunt chest trauma/injuries to the thorax: Patient with blunt chest trauma (with or without polytrauma) before SSRF implantation and subsequent hardware removal

• Rib fracture: At least one rib fracture (unilateral and/or bilateral incl. flail chest) on radiography chest imaging on time of SSRF implantation. Patients with rib fracture/non-union due to pseudoarthrosis are included.

• Rib fixation material implantation and removal: Patient underwent surgery for rib fracture and implantation of at least one (partially or complete) rib fixation material (at any time point) with later hardware removal (partially or complete) (at any time point between 01.09.2017 and 30.09.2023)

• Patient of all gender

• Patient =18 years at time point of rib stabilization

• Signed written informed consent prior to initiation of any protocol-specific activities/procedure

• Patient will be included if a signed USB general research consent approval is available but patient cannot be reached or disagreed to come to the follow-up visit

• Patient who died will be included if a signed USB general research consent approval is available

Exclusion Criteria:

• Patients who received re-osteosynthesis on the same day as hardware removal

• Patients received conservative therapy or surgery with absorbable plates

• On hardware implantation:

• Penetrating chest trauma

• Only random findings of rib fractures

• Solitary sternocostal joint fracture and/or solitary sternum fracture and/or solitary fractures of rib connecting parts and/or solitary thoracic spine/vertebra fracture

• In-hospital: Patient suffered only iatrogenic rib facture during a surgery, cardiac surgery

• Rib fractures/non-unions caused by malignancy or rib surgery due to malignancy, radiation therapy, COPD, coughing

• Inability to follow procedures or insufficient knowledge of language (German/French) or impaired communication or inability to give consent

• Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes

Related Conditions & MeSH terms

• Rib Fractures
• Thoracic Injuries

Intervention

Other:
• Data collection on patient reported long-term outcome of SSRF hardware removal
One prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey.

Locations

Country	Name	City	State
Switzerland	Department of Thoracic Surgery, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health survey of long-term outcome after hardware removal (Quality of life assessment)	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.	One time assessment at baseline (prospective Follow up-visit)
Secondary	Number of removed hardware	Number of removed hardware and affected ribs (retrospective analyses)	Up to 3 years until prospective Follow up-visit
Secondary	Number of broken and fixed ribs	Number of broken and fixed ribs with used hardware (retrospective analyses)	Up to 3 years until prospective Follow up-visit
Secondary	Interval between SSRF and hardware removal	Interval between SSRF and hardware removal (retrospective analyses)	Up to 3 years until prospective Follow up-visit
Secondary	Interval between SSRF and follow-up visit	Interval between SSRF and follow-up visit (retrospective analyses)	Up to 3 years until prospective Follow up-visit
Secondary	Occurrence of significant complications during and 30 days after SSRF hardware removal	Occurrence of significant complications during and 30 days after SSRF hardware removal (retrospective analyses)	Up to 3 years until prospective Follow up-visit
Secondary	Surgical indication for hardware removal	Surgical indication for hardware removal	Up to 3 years until prospective Follow up-visit