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

Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Fractures - a Multicenter Study From the German Pelvic Registry

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.

Study Overview

• Status: Completed
• Conditions: Acetabular Fracture; Polytrauma; Abdominal Trauma; Pelvic Ring Fracture
• Intervention / Treatment: Procedure: osteosynthesis of the pelvis

Detailed Description

The German Pelvic Registry of the German Trauma Society is a multicenter prospective registry which collects data of patients with pelvic injuries since 2003. Beside demographic data (including concomitant injuries) allowing for epidemiological evaluations of the development of surgical care in these patients, namely the operative care is focus of this registry. Beside the chosen procedure or surgical approach, this includes both intraoperative data like time until operation, duration of the procedure or intraoperative blood loss and reduction parameters (pre- and postoperative fracture steps). The clinical course is recorded also including overall morbidity, overall mortality and osteosynthesis-related complications.

The influence of a concomitant abdominal trauma on the quality of care regarding operative parameters like reduction quality or the clinical course in pelvic injuries has not been investigated yet.

The investigators therefore retrospectively analyze the prospective consecutive data of patients from the multicenter German Pelvic Registry of the German Trauma Society in the years 2003 - 2017. Demographic, clinical and operative parameter were recorded and compared in two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma).

• Study Type: Observational
• Enrollment (Actual): 16359

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • BG Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Pelvic fracture

Exclusion Criteria:

• no agreement to participate in the registry

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
isolated pelvic fracture; Patients with an isolated pelvic fracture	Procedure: osteosynthesis of the pelvis; Osteosynthetic Fixation of the pelvic fracture
combined abodominal/pelvic injury; Patients with a combined injury of a pelvic fracture and an abdominal injury.	Procedure: osteosynthesis of the pelvis; Osteosynthetic Fixation of the pelvic fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
osteosynthesis-associated complications	Rate of osteosynthesis-associated complications	through study completion, at least 1 year after inclusion
length of hospital stay	Duration of the inpatient Treatment, measured in days.	through study completion, at least 1 year after inclusion
Time until definitive pelvic surgery	The time until the definitive surgical procedure for the pelvic fracture, measured in days.	through study completion, at least 1 year after inclusion

Collaborators and Investigators

• Sponsor: BG Trauma Center Tuebingen
• Investigators: Principal Investigator: Markus A Küper, MD, BG Trauma Center Tübingen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: May 11, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Polytrauma; Pelvic trauma; Pelvic ring fracture; Acetabular Fracture; Abdominal Trauma; Reduction quality
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Multiple Trauma; Abdominal Injuries
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No