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Completed

NCT Number: NCT03952026

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

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.

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Key information

Conditions

Pelvic Ring Fracture Abdominal Injuries Abdominal Trauma Acetabular Fracture Multiple Trauma Polytrauma Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

BG Trauma Center

Tübingen, 72076, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pelvic fracture

Exclusion criteria

  • no agreement to participate in the registry

Treatment and study plan

osteosynthesis of the pelvis

Procedure

Osteosynthetic Fixation of the pelvic fracture

Primary outcomes

  1. "Matta" Grading

    Time frame: 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

    Time frame: through study completion, at least 1 year after inclusion

    Rate of overall complications

Secondary outcomes

  1. osteosynthesis-associated complications

    Time frame: through study completion, at least 1 year after inclusion

    Rate of osteosynthesis-associated complications

  2. length of hospital stay

    Time frame: through study completion, at least 1 year after inclusion

    Duration of the inpatient Treatment, measured in days.

  3. Time until definitive pelvic surgery

    Time frame: through study completion, at least 1 year after inclusion

    The time until the definitive surgical procedure for the pelvic fracture, measured in days.

Sponsors and collaborators

Lead sponsor

BG Trauma Center Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 16, 2019
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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