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Not yet recruitingNCT06540339Updated Dec 12, 2024

A Snapshot Audit of Traumatic Pelvic Ring Injuries

An observational study in Pelvic Trauma, Pelvic Fracture and Fragility Fractures of the Pelvis (FFP), sponsored by University Hospital, Aachen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by University Hospital, Aachen · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Pelvic Trauma
  • Pelvic Fracture
  • Fragility Fractures of the Pelvis (FFP)

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03

In context

Hip Fractures

842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.

This study's planned enrollment of 500 is above the median of 149 across 280 observational studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

University Hospital, Aachen is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Concomitant acetabular fractures
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with high-energy pelvic ring injuries

    Other: 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.

  • Pratients with fragility fractures of the pelvis

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

Interventions

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

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

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bass GA, Kaplan LJ, Ryan EJ, Cao Y, Lane-Fall M, Duffy CC, Vail EA, Mohseni S. The snapshot audit methodology: design, implementation and analysis of prospective observational cohort studies in surgery. Eur J Trauma Emerg Surg. 2023 Feb;49(1):5-15. doi: 10.1007/s00068-022-02045-3. Epub 2022 Jul 15. PubMed 35840703 ↗
  • Bass GA, Gillis A, Cao Y, Mohseni S; European Society for Trauma, Emergency Surgery (ESTES) Cohort Studies Group. Patterns of prevalence and contemporary clinical management strategies in complicated acute biliary calculous disease: an ESTES 'snapshot audit' of practice. Eur J Trauma Emerg Surg. 2022 Feb;48(1):23-35. doi: 10.1007/s00068-020-01433-x. Epub 2020 Jul 7. Erratum In: Eur J Trauma Emerg Surg. 2022 Feb;48(1):37-38. doi: 10.1007/s00068-021-01650-y. PubMed 32632631 ↗
  • Enninghorst N, Toth L, King KL, McDougall D, Mackenzie S, Balogh ZJ. Acute definitive internal fixation of pelvic ring fractures in polytrauma patients: a feasible option. J Trauma. 2010 Apr;68(4):935-41. doi: 10.1097/TA.0b013e3181d27b48. PubMed 20386287 ↗
  • Ertel W, Keel M, Eid K, Platz A, Trentz O. Control of severe hemorrhage using C-clamp and pelvic packing in multiply injured patients with pelvic ring disruption. J Orthop Trauma. 2001 Sep-Oct;15(7):468-74. doi: 10.1097/00005131-200109000-00002. PubMed 11602828 ↗
  • Logters T, Lefering R, Schneppendahl J, Alldinger I, Witte I, Windolf J, Flohe S; TraumaRegister der DGU. [Interruption of the diagnostic algorithm and immediate surgical intervention after major trauma--incidence and clinical relevance. Analysis of the Trauma Register of the German Society for Trauma Surgery]. Unfallchirurg. 2010 Oct;113(10):832-8. doi: 10.1007/s00113-010-1772-1. German. PubMed 20393832 ↗
  • Timmer RA, Mostert CQB, Krijnen P, Meylaerts SAG, Schipper IB. The relation between surgical approaches for pelvic ring and acetabular fractures and postoperative complications: a systematic review. Eur J Trauma Emerg Surg. 2023 Apr;49(2):709-722. doi: 10.1007/s00068-022-02118-3. Epub 2022 Nov 25. PubMed 36434301 ↗
  • Kuper MA, Trulson A, Stuby FM, Stockle U. Pelvic ring fractures in the elderly. EFORT Open Rev. 2019 Jun 3;4(6):313-320. doi: 10.1302/2058-5241.4.180062. eCollection 2019 Jun. PubMed 31312519 ↗
  • Parry JA, Funk A, Heare A, Stacey S, Mauffrey C, Starr A, Crist B, Krettek C, Jones CB, Kleweno CP, Firoozabadi R, Sagi HC, Archdeacon M, Eastman J, Langford J, Oransky M, Martin M, Cole P, Giannoudis P, Byun SE, Morgan SJ, Smith W, Giordano V, Trikha V. An international survey of pelvic trauma surgeons on the management of pelvic ring injuries. Injury. 2021 Oct;52(10):2685-2692. doi: 10.1016/j.injury.2020.07.027. Epub 2020 Jul 11. PubMed 32943214 ↗
  • Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8. PubMed 8915200 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2025; primary completion for Nov 2025, 8 months later.

Of 107 non-industry observational studies under Hip Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's planned 8 months is below that.

Counting every sponsor, half of 124 studies reached it within 28 months; a quarter within 12 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2024
First posted
Aug 6, 2024
StartEst.
Mar 1, 2025
Primary completionEst.
Nov 30, 2025
CompletionEst.
Nov 30, 2026
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06540339
Lead sponsor
University Hospital, Aachen
Collaborators
European Society for Trauma and Emergency Surgery
Responsible party
Dr. med. Eftychios Bolierakis (Dr. med. Eftychios Bolierakis, University Hospital, Aachen) — Principal investigator
First posted
Aug 6, 2024
Start date
Mar 1, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Dec 12, 2024

Study contacts

Eftychios Bolierakis
Contact
ebolierakis@ukaachen.de
004902418036627
Frank Hildebrand, Prof. Dr.
study chair · University Hospital, Aachen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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