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

NCT06003595 | Completed

• 1 other identifier: 2023-01191; kt23Lardinois3
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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 blunt chest trauma .

Conditions

Rib Fractures

Keywords

surgical stabilization of rib fractures (SSRF); hardware failure; hardware-related complications; hardware removal; blunt chest trauma; rib osteosynthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of removed hardware

  Up to 3 years until prospective Follow up-visit

• Number of broken and fixed ribs

  Up to 3 years until prospective Follow up-visit

• Interval between SSRF and hardware removal

  Up to 3 years until prospective Follow up-visit

• Interval between SSRF and follow-up visit

  Up to 3 years until prospective Follow up-visit

• Occurrence of significant complications during and 30 days after SSRF hardware removal

  Up to 3 years until prospective Follow up-visit

Study Arms (1)

Surgical stabilization of rib fractures (SSRF) and subsequent hardware removal

Patients treated at the Department of Thoracic Surgery at the University Hospital Basel between 01.09.2017 and start date Remove Study with a diagnosis of rib fracture and with surgical stabilization of rib fracture and subsequent hardware removal will be identified.

Other: Data collection on patient reported long-term outcome of SSRF hardware removal

Interventions

Data collection on patient reported long-term outcome of SSRF hardware removal OTHER

One prospective follow-up visit will be performed. On this visit the patient reported long-term outcome will be documented through a health survey.

Surgical stabilization of rib fractures (SSRF) and subsequent hardware removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with blunt chest trauma who underwent hardware removal after rib stabilisation between September 01, 2017 and September 30, 2023. The patients received hardware implantation and hardware removal at the Department of Thoracic Surgery of the University Hospital Basel.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Thoracic Surgery, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Svec MB, Bachmann H, Hojski A, Macharia-Nimietz EF, Dackam SVC, Lardinois D. Long-term outcomes after removal of rib stabilization hardware in patients with blunt chest trauma. Eur J Trauma Emerg Surg. 2025 Apr 29;51(1):187. doi: 10.1007/s00068-025-02858-y.

  PMID: 40299046 RESULT

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Maria Stepankova, MD

  Department of Thoracic Surgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 22, 2023
• Study Start: August 4, 2023
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

CH (1)