Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Injuries

NCT03952026 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 16,359
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. On the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. The combination of both injuries is a challenge for orthopedic surgeons, as the abdominal injury might lead to a delayed surgical treatment of the pelvic fracture. Whether an associated abdominal injury influences the quality of care of pelvic fractures, is aim of this registry study.

Conditions

Pelvic Ring Fracture; Acetabular Fracture; Abdominal Trauma; Polytrauma

Keywords

Pelvic trauma; Pelvic ring fracture; Acetabular Fracture; Abdominal Trauma; Polytrauma; Reduction quality

Outcome Measures

Primary Outcomes (2)

• "Matta" Grading

  Quality of the reduction of the pelvic fracture measured in mm residual step at the fracture's site. A residual step of 0-2mm is graded as an "anatomical reduction" (=Matta 1), a residual step of 2-3mm is graded as an "Imperfect reduction" (=Matta 2) and a residual step \>3mm is graded as a "poor reduction" (=Matta 3).

  through study completion, at least 1 year after inclusion

• Overall morbidity

  Rate of overall complications

  through study completion, at least 1 year after inclusion

Secondary Outcomes (3)

• osteosynthesis-associated complications

  through study completion, at least 1 year after inclusion

• length of hospital stay

  through study completion, at least 1 year after inclusion

• Time until definitive pelvic surgery

  through study completion, at least 1 year after inclusion

Study Arms (2)

isolated pelvic fracture

Patients with an isolated pelvic fracture

Procedure: osteosynthesis of the pelvis

combined abodominal/pelvic injury

Patients with a combined injury of a pelvic fracture and an abdominal injury.

Procedure: osteosynthesis of the pelvis

Interventions

osteosynthesis of the pelvis PROCEDURE

Osteosynthetic Fixation of the pelvic fracture

combined abodominal/pelvic injury; isolated pelvic fracture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a pelvic fracture Group 1: isolated pelvic fracture Group 2: combined abdominal/pelvic injury

You may qualify if:

• Pelvic fracture

You may not qualify if:

• no agreement to participate in the registry

Sponsors & Collaborators

• BG Trauma Center Tuebingen: lead

Study Sites (1)

BG Trauma Center

Tübingen, 72076, Germany

Location

Related Publications (1)

• Kuper MA, Bachmann R, Wenig GF, Ziegler P, Trulson A, Trulson IM, Minarski C, Ladurner R, Stockle U, Hoch A, Herath SC, Stuby FM; Working Group on Pelvic Fractures of the German Trauma Society. Associated abdominal injuries do not influence quality of care in pelvic fractures-a multicenter cohort study from the German Pelvic Registry. World J Emerg Surg. 2020 Jan 17;15:8. doi: 10.1186/s13017-020-0290-x. eCollection 2020.

  PMID: 31988652 DERIVED

MeSH Terms

Conditions

Abdominal Injuries; Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Markus A Küper, MD

  BG Trauma Center Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 16, 2019
• Study Start: December 6, 2018
• Primary Completion: December 31, 2018
• Study Completion: May 10, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

DE (1)