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

Sponsor
BG Trauma Center Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT03952026
Collaborator
(none)
16,359
1
5.1
3212.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
16359 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Fractures - a Multicenter Study From the German Pelvic Registry
Actual Study Start Date :
Dec 6, 2018
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
May 10, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. "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).

  2. Overall morbidity [through study completion, at least 1 year after inclusion]

    Rate of overall complications

Secondary Outcome Measures

  1. osteosynthesis-associated complications [through study completion, at least 1 year after inclusion]

    Rate of osteosynthesis-associated complications

  2. length of hospital stay [through study completion, at least 1 year after inclusion]

    Duration of the inpatient Treatment, measured in days.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pelvic fracture
Exclusion Criteria:
  • no agreement to participate in the registry

Contacts and Locations

Locations

Site City State Country Postal Code
1 BG Trauma Center Tübingen Germany 72076

Sponsors and Collaborators

  • BG Trauma Center Tuebingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Markus Küper, Principal Investigator, BG Trauma Center Tuebingen
ClinicalTrials.gov Identifier:
NCT03952026
Other Study ID Numbers:
  • 001
First Posted:
May 16, 2019
Last Update Posted:
May 16, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Markus Küper, Principal Investigator, BG Trauma Center Tuebingen
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2019