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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003595
Collaborator
(none)
20
1
4
5

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Other: data collection on patient reported long-term outcome of SSRF hardware removal

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 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-term Outcome After Removal of Rib Stabilization Hardware in Patients With Blunt Chest Trauma
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Health survey of long-term outcome after hardware removal (Quality of life assessment) [one time assessment at baseline (prospective Follow up-visit)]

    The questions are formulated as an adapted question set of the EuroQol-5 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.

Secondary Outcome Measures

  1. Number of removed hardware [up to 3 years until prospective Follow up-visit]

    Number of removed hardware at affected ribs (retrospective analyses)

  2. Number of broken and fixed ribs [up to 3 years until prospective Follow up-visit]

    Number of broken and fixed ribs with used hardware (retrospective analyses)

  3. Interval between SSRF and hardware failure [up to 3 years until prospective Follow up-visit]

    Interval between SSRF and hardware failure (retrospective analyses)

  4. Interval between SSRF and hardware removal [up to 3 years until prospective Follow up-visit]

    Interval between SSRF and hardware removal (retrospective analyses)

  5. Interval between SSRF and follow-up visit [up to 3 years until prospective Follow up-visit]

    Interval between SSRF and follow-up visit (retrospective analyses)

  6. Occurrence of significant complications during and 30 days after SSRF hardware removal [up to 3 years until prospective Follow up-visit]

    Occurrence of significant complications during and 30 days after SSRF hardware removal (retrospective analyses)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. Patients with rib fracture/non-union due to pseudo arthrosis are included.

  • Rib fracture: At least one rib fracture (unilateral and or bilateral incl. flail chest) on radiography chest imaging on time of SSRF implantation

  • 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 start date Remove Study)

  • Patients 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

  • Patients 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

  • Random findings of rib fractures

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

  • In-hospital: Patient suffered new rib fracture during a surgery, cardiac surgery

  • Rib fractures/non-unions due to malignancy, radiation therapy, chronic obstructive pulmonary disease (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Thoracic Surgery, University Hospital Basel Basel Switzerland 4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Maria Stepankova, MD, Department of Thoracic Surgery, University Hospital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT06003595
Other Study ID Numbers:
  • 2023-01191; kt23Lardinois3
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023