A Snapshot Audit of Traumatic Pelvic Ring Injuries

December 7, 2024 updated by: Dr. med. Eftychios Bolierakis, University Hospital, Aachen

SnapPelvis: International Prospective Observational Cohort Study of Traumatic Pelvic Ring Injuries

Multicenter, snapshot cohort studies or audits have the ability to gather large patient numbers in short time periods from many healthcare systems with different resources or practices of care concerning one specific surgical condition. This type of studies allows exploration of differences in patient populations and management across the sampled cohort to identify areas of practice variability that may result in apparent differences in outcome. As such, whilst not providing true evidence of efficacy or the impact of a single variable on overall outcome, these studies can be hypothesis-generating and identify areas warranting further study in future randomized controlled trials (1). Snapshots also shed light on the real world practice, rather than the presumed or guideline suggested patient care (2).

Traumatic Pelvic Ring Injuries (TPRI) represent a broad spectrum of trauma-associated pathologies with a distinct bimodal age distribution in patients admitted through the Emergency Departments of all acute care hospitals. In younger patients, this type of injury is often associated with high-energy trauma, hemodynamic instability, high mortality and morbidity rates (3-6). In the elderly population, pelvic fractures result from low energy trauma mechanisms (e.g. ground level fall) and can affect the long-term independency and life quality of geriatric patients (7).

There is substantial variation in the management of pelvic ring injuries among pelvic trauma surgeons; these variations include but are not limited to the timing of definitive fixation, the indications and protocols of conservative treatment, and the appropriate osteosynthesis of the anterior and/or posterior pelvic fractures (8).

This 'ESTES snapshot audit' -a prospective observational cohort study- has a dual purpose. Firstly, as an epidemiological study, it aims to report the burden of injury in specific hospitals, distributed widely throughout Europe. Secondly, this study aims to demonstrate current strategies for both, younger (after high-energy trauma) and geriatric patients (after low-energy trauma) employed to assess and treat these patients. These twin aims will serve to provide a 'snapshot' of current medical practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of particular clinical questions. The acquired study data can be subsequently evaluated and compared to patient data of established pelvic trauma registries across Europe.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients diagnosed in the emergency department of participating hospitals across Europe with traumatic pelvic ring injuries over a 3-month period.

Description

Inclusion Criteria:

  • Adult patients (≥18 years of age) admitted for traumatic pelvic ring injuries (AO/FFP-Classification).

Exclusion Criteria:

  • Concomitant acetabular fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with high-energy pelvic ring injuries
Other: Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
Patients with complex pelvic trauma
Other: Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
Pratients with fragility fractures of the pelvis
Other: Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
Snapshot-audit studies do not necessitate any intervention in the defined cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality after traumatic pelvic ring injuries
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of systemic complications after traumatic pelvic ring injuries
Time Frame: 6 months
6 months
Re-admission rate for fracture-related implant failure, infections and re-operations within 6 months after traumatic pelvic ring injuries
Time Frame: 6 months
6 months
Pelvic Outcome Score after traumatic pelvic ring injuries
Time Frame: 6 months
The Pelvic Outcome Score reflects the outcome after treatment of traumatic pelvic ring injuries. It assesses following three parameters: radiological result (max. 3 points), clinical result (max. 4 points) and social reintegration (max. 3 points). The maximum of 10 points represents an excellent result, while the minimum of 3 points corresponds to the worst outcome (9).
6 months
Rate of social reintegration after traumatic pelvic ring injuries
Time Frame: 6 months
Rate of retaining same profession, recreational status, activity level in sports and social situation as prior to accident. This outcome measure will be assessed through a questionnaire.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Aachen

Collaborators

European Society for Trauma and Emergency Surgery

Investigators

  • Study Chair: Frank Hildebrand, Prof. Dr., University Hospital, Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 520741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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