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

Polytrauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952026
• Other study ID #: 001
• Status: Completed
• Start date: December 6, 2018
• Est. completion date: May 10, 2019

Study information

• Verified date: May 2019
• Source: BG Trauma Center Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16359
• Est. completion date: May 10, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pelvic fracture

Exclusion Criteria:

• no agreement to participate in the registry

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Trauma
• Acetabular Fracture
• Fractures, Bone
• Multiple Trauma
• Pelvic Ring Fracture
• Polytrauma

Intervention

Procedure:
• osteosynthesis of the pelvis
Osteosynthetic Fixation of the pelvic fracture

Locations

Country	Name	City	State
Germany	BG Trauma Center	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
BG Trauma Center Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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
Primary	Overall morbidity	Rate of overall complications	through study completion, at least 1 year after inclusion
Secondary	osteosynthesis-associated complications	Rate of osteosynthesis-associated complications	through study completion, at least 1 year after inclusion
Secondary	length of hospital stay	Duration of the inpatient Treatment, measured in days.	through study completion, at least 1 year after inclusion
Secondary	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