Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Basel, Switzerland

Conditions:

Rib Fractures

Eligibility:

All Genders

18+ years

Brief 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 b...

Detailed 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 SS...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 4 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 8 2024

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT06003595

Start Date

August 4 2023

End Date

January 8 2024

Last Update

May 11 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Thoracic Surgery, University Hospital Basel

Basel, Switzerland, 4031