Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT06003595
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06003595
Study Brief:
Protocol Section:
NCT06003595