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Pelvic Fractures in the Elderly (PelvFx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03476824
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
The aim of the project is to predict the patient under conservative therapy as a function of the patient Classification of Rommens and Hofmann and other potential prognostic factors. A corresponding prognostic score may be used in the future by patients and attending physicians support joint decision between surgical and conservative treatment.

Condition or disease
Pelvic Fracture

Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: PelvFx - Pelvic Fractures in the Elderly Patient Influence of Fracture Classification According to Rommens & Hofmann on Mobility, Operation and Independence
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. mortality [ Time Frame: from pelvic fracture until year 1 ]
    number of patients who died within one year after pelvic fracture

  2. loss of independence [ Time Frame: from pelvic fracture until year 1 ]
    loss of independence defined as number of patients leaving their own home and starting to live in a retirement home or asylum within one year after pelvic fracture


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients are filtered out of our electronic patient system on the basis of the diagnosis "pelvic ring fracture". Subsequently, patients under the age of 60 and patients after high-energy trauma are excluded.
Criteria

Inclusion Criteria:

  • Pelvic fracture after low-energy trauma
  • Treatment in the years 2006 to 2016
  • patients equal to or older than 60 years

Exclusion Criteria:

  • Pelvic fracture after a high-energy space
  • Pathological fracture in the area of a tumor or a bony metastasis
  • Existence of a documented refusal
Contacts and Locations
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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): NCT03476824


Locations
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Switzerland
University Hospital Switzerland, Traumatology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Michaela Ramser, MD University Hospital, Basel, Switzerland
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03476824    
Other Study ID Numbers: 2017-01859; ch18Ramser
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries