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

Completed

• Conditions: Abdominal Trauma; Polytrauma; Pelvic Ring Fracture; Acetabular Fracture
• Interventions: Procedure: osteosynthesis of the pelvis

• Registration Number: NCT03952026
• Lead Sponsor: BG Trauma Center Tuebingen

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.

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 Timeline

• Study Start: 2018-12-06
• Primary Completion: 2018-12-31
• Status Verified: 2019-05
• Study Completion: 2019-05-10
• Study First Submitted: 2019-05-11
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16359

Inclusion Criteria

• Pelvic fracture

Exclusion Criteria

• no agreement to participate in the registry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
combined abodominal/pelvic injury	osteosynthesis of the pelvis	Patients with a combined injury of a pelvic fracture and an abdominal injury.
isolated pelvic fracture	osteosynthesis of the pelvis	Patients with an isolated pelvic fracture

Primary Outcome Measures

Name	Time	Method
"Matta" Grading	through study completion, at least 1 year after inclusion	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).
Overall morbidity	through study completion, at least 1 year after inclusion	Rate of overall complications

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BG Trauma Center; 🇩🇪 Tübingen, Germany