A Snapshot Audit of Traumatic Pelvic Ring Injuries

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Aachen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Concomitant acetabular fractures

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Patients with high-energy pelvic ring injuries1 intervention
Group B: Patients with complex pelvic trauma1 intervention
Group C: Pratients with fragility fractures of the pelvis1 intervention

Trial outcomes

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

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).

Time frame
6 months
4

Rate of social reintegration after traumatic pelvic ring injuries

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.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Aachen

Lead sponsor

European Society for Trauma and Emergency Surgery

Collaborator

This trial is not recruiting at the moment. You can still explore other options: