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NCT Number: NCT06540339

A Snapshot Audit 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Concomitant acetabular fractures

Treatment and study plan

Snapshot-audit studies do not necessitate any intervention in the defined cohorts.

Other

Snapshot-audit studies do not necessitate any intervention in the defined cohorts.

Primary outcomes

  1. Mortality after traumatic pelvic ring injuries

    Time frame: 6 months

Secondary outcomes

  1. Rate of systemic complications after traumatic pelvic ring injuries

    Time frame: 6 months

  2. Re-admission rate for fracture-related implant failure, infections and re-operations within 6 months after traumatic pelvic ring injuries

    Time frame: 6 months

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eftychios Bolierakis

CONTACT

[email protected]

004902418036627

Sponsors and collaborators

Lead sponsor

University Hospital, Aachen

Other

Collaborators

  • European Society for Trauma and Emergency Surgery

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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