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

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ClinicalTrials.gov Identifier: NCT03952026
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Markus Küper, 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.

Condition or disease Intervention/treatment
Pelvic Ring Fracture Acetabular Fracture Abdominal Trauma Polytrauma 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).


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Study Type : Observational [Patient Registry]
Actual Enrollment : 16359 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
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 : December 6, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : May 10, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a pelvic fracture Group 1: isolated pelvic fracture Group 2: combined abdominal/pelvic injury
Criteria

Inclusion Criteria:

  • Pelvic fracture

Exclusion Criteria:

  • no agreement to participate in the registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952026


Locations
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Germany
BG Trauma Center
Tübingen, Germany, 72076
Sponsors and Collaborators
BG Trauma Center Tuebingen
Investigators
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Principal Investigator: Markus A Küper, MD BG Trauma Center Tübingen

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Responsible Party: Markus Küper, Principal Investigator, BG Trauma Center Tuebingen
ClinicalTrials.gov Identifier: NCT03952026     History of Changes
Other Study ID Numbers: 001
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Markus Küper, BG Trauma Center Tuebingen:
Pelvic trauma
Pelvic ring fracture
Acetabular Fracture
Abdominal Trauma
Polytrauma
Reduction quality

Additional relevant MeSH terms:
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Fractures, Bone
Multiple Trauma
Abdominal Injuries
Wounds and Injuries