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Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

NCT ID: NCT06464289

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35974 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-13

Study Completion Date

2024-09-30

Brief Summary

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The aim of the study is to investigate the effect of surgical stabilisation of rib fractures on clinical outcomes in patients that are not dependent on mechanical ventilation at the time of the treatment decision. To this end, data on all eligible patients will be extracted from the TraumaRegister® DGU. Baseline demographics will be analysed using descriptive statistics. Propensity matching will be conducted between the operative cohort (receiving SSRF by any technique) and the conservative cohort (not receiving SSRF). The effect of SSRF on the outcome variables will then be assessed using appropriate statistical tests.

Detailed Description

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Conditions

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Rib Fractures Thorax; Fracture

Keywords

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surgical stabilisation of rib fractures non-ventilator-dependent

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Operative

Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique

Surgical stabilisation of rib fractures (SSRF)

Intervention Type PROCEDURE

Surgical stabilisation of rib fractures using any fixation technique (including but not limited to plate fixation, intramedullary fixation, wire fixation) via any operative approach (including but not limited to open external approach, minimally invasive approach, thoracoscopic approach, thoracotomy approach).

Non-operative management of rib fractures

Intervention Type OTHER

Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation.

Non-operative

Patients not receiving surgical stabilisation of rib fractures (SSRF)

Non-operative management of rib fractures

Intervention Type OTHER

Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation.

Interventions

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Surgical stabilisation of rib fractures (SSRF)

Surgical stabilisation of rib fractures using any fixation technique (including but not limited to plate fixation, intramedullary fixation, wire fixation) via any operative approach (including but not limited to open external approach, minimally invasive approach, thoracoscopic approach, thoracotomy approach).

Intervention Type PROCEDURE

Non-operative management of rib fractures

Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Rib AIS of ≥ 3
* Initial hospital treatment

Exclusion Criteria

* Intubated preclinically or in the emergency department
* Glasgow coma scale (GCS) \< 9 at the time of the primary survey in the emergency department
* No in-patient hospital management
Minimum Eligible Age

10 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TraumaRegister® DGU

UNKNOWN

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steffen Rosslenbroich, PD Dr. med.

Role: STUDY_DIRECTOR

Department for trauma, hand and reconstructive surgery, University hospital Muenster

Locations

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Department for trauma, hand and reconstructive surgery, University hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Huelskamp MD, Duesing H, Lefering R, Raschke MJ, Rosslenbroich S; TraumaRegister DGU. Surgical stabilisation of rib fractures in non-ventilated patients: a retrospective propensity-matched analysis using the data from the trauma registry of the German Trauma Society (TraumaRegister DGUⓇ). Eur J Trauma Emerg Surg. 2025 Jan 24;51(1):55. doi: 10.1007/s00068-024-02756-9.

Reference Type DERIVED
PMID: 39856261 (View on PubMed)

Other Identifiers

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2023-007

Identifier Type: OTHER

Identifier Source: secondary_id

UKM_UCH_2024_001

Identifier Type: -

Identifier Source: org_study_id