A Snapshot Audit of Traumatic Pelvic Ring Injuries

NCT06540339 | Not Yet Recruiting

• 1 other identifier: 520741
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mortality after traumatic pelvic ring injuries

  6 months

Secondary Outcomes (4)

• Rate of systemic complications after traumatic pelvic ring injuries

  6 months

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

  6 months

• Pelvic Outcome Score after traumatic pelvic ring injuries

  6 months

• Rate of social reintegration after traumatic pelvic ring injuries

  6 months

Study Arms (3)

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

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.

Patients with complex pelvic trauma; Patients with high-energy pelvic ring injuries; Pratients with fragility fractures of the pelvis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Concomitant acetabular fractures

Sponsors & Collaborators

• University Hospital, Aachen: lead
• European Society for Trauma and Emergency Surgery: collaborator

Related Publications (9)

• 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.

  PMID: 35840703 BACKGROUND

• 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.

  PMID: 32632631 BACKGROUND

• 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.

  PMID: 20386287 BACKGROUND

• 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.

  PMID: 11602828 BACKGROUND

• 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.

  PMID: 20393832 BACKGROUND

• 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.

  PMID: 36434301 BACKGROUND

• 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.

  PMID: 31312519 BACKGROUND

• 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.

  PMID: 32943214 BACKGROUND

• Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8.

  PMID: 8915200 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Frank Hildebrand, Prof. Dr.

  University Hospital, Aachen

  STUDY CHAIR

Central Study Contacts

Eftychios Bolierakis

CONTACT

004902418036627; ebolierakis@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Eftychios Bolierakis

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: August 6, 2024
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share