Pelvic TraumaNCT06540339
A Snapshot Audit of Traumatic Pelvic Ring Injuries
An observational study of Pelvic Trauma and Pelvic Fracture, run by University Hospital, Aachen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Trauma, Pelvic Fracture, Fragility Fractures of the Pelvis (FFP)
- What is being tested?
- Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients diagnosed in the emergency department of participating hospitals across Europe with traumatic pelvic ring injuries over a 3-month period.
Who may be able to join
- Adult patients (≥18 years of age) admitted for traumatic pelvic ring injuries (AO/FFP-Classification).
Who cannot join
- Concomitant acetabular fractures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read more
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.
- Being tested
- Snapshot-audit studies do not necessitate any intervention in the defined cohorts.
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with high-energy pelvic ring injuries | Not described Receives: Other: Snapshot-audit studies do not necessitate any intervention in the defined cohorts. | |
| Patients with complex pelvic trauma | Not described Receives: Other: Snapshot-audit studies do not necessitate any intervention in the defined cohorts. | |
| Pratients with fragility fractures of the pelvis | Not described Receives: Other: Snapshot-audit studies do not necessitate any intervention in the defined cohorts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality after traumatic pelvic ring injuries
Measured: 6 months
Secondary outcomes (4)
Rate of systemic complications after traumatic pelvic ring injuries
Measured: 6 months
Re-admission rate for fracture-related implant failure, infections and re-operations within 6 months after traumatic pelvic ring injuries
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Mar 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aachen
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Trauma and Emergency Surgery
- Responsible party
- Principal investigator, Dr. med. Eftychios Bolierakis, University Hospital, Aachen
- Investigators
- Frank Hildebrand, Prof. Dr., Study chair, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540339
- Sponsor's protocol ID
- 520741
- Status last verified
- Dec 2024
- First submitted
- 20 Jul 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35840703Bass 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.
PubMed 32632631Enninghorst 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 20386287Ertel 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 11602828Logters 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 20393832Timmer 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 36434301Kuper 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 31312519Parry 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 32943214Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8.
PubMed 8915200
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SnapPelvis: International Prospective Observational Cohort Study of Traumatic Pelvic Ring Injuries
- ClinicalTrials.gov ID
- NCT06540339
- Acronym / sponsor ID
- 520741
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AachenUniversity, hospital or other
- Collaborators
- European Society for Trauma and Emergency Surgery
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients diagnosed in the emergency department of participating hospitals across Europe with traumatic pelvic ring injuries over a 3-month period.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years of age) admitted for traumatic pelvic ring injuries (AO/FFP-Classification).
Key exclusion criteria (1 listed)
- Concomitant acetabular fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snapshot-audit studies do not necessitate any intervention in the defined cohorts.Snapshot-audit studies do not necessitate any intervention in the defined cohorts. | Other | Patients with complex pelvic trauma, Patients with high-energy pelvic ring injuries, Pratients with fragility fractures of the pelvis |
Primary outcome
Mortality after traumatic pelvic ring injuries
Time frame: 6 months
4 secondary outcomes
Rate of systemic complications after traumatic pelvic ring injuries
Time frame: 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
Pelvic Outcome Score after traumatic pelvic ring injuries
Time frame: 6 months
Rate of social reintegration after traumatic pelvic ring injuries
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 35840703Bass 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.
- Background: PubMed 32632631Bass 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.
- Background: PubMed 20386287Enninghorst 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.
- Background: PubMed 11602828Ertel 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.
- Background: PubMed 20393832Logters 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.
- Background: PubMed 36434301Timmer 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.
- Background: PubMed 31312519Kuper 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.
- Background: PubMed 32943214Parry 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.
- Background: PubMed 8915200Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Hildebrand, Prof. Dr. study chair
University Hospital, Aachen
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Trauma and Pelvic Fracture, run by University Hospital, Aachen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eftychios Bolierakis (004902418036627, ebolierakis@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality after traumatic pelvic ring injuries (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540339, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.