Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
420 participants
OBSERVATIONAL
2022-03-01
2026-06-30
Brief Summary
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Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).
Detailed Description
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* To identify the difference in patient related outcome comparing the surgical and conservative treatment in patients suffering from an FFP with different levels of pelvic instability at different time points
* To compare the rate of complications, morbidity and mortality between the different treatment modalities over the whole study period
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pelvis fracture type II to IV
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis, via CT scan as per standard of care, of FFP grade II or higher according to the Rommens and Hofmann classification (including fractures of the anterior pelvic ring involving the anterior lip of the acetabulum not regarded as the acetabular fractures)
* Informed consent obtained, ie:
* Ability to understand the content of the patient information/ICF
* Willingness and ability to participate in the registry according to the standard of care in each clinic
* Signed and dated Ethics Committee (EC)/ Institutional Review Board (IRB) approved written informed consent OR
* Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
Exclusion Criteria
* FFP type I fractures
* Concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above)
* Pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections)
* Concomitant osteoporotic fractures outside of pelvis
* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present registry
65 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Pol Maria Rommens, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Johannes Gutenberg-University
Locations
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University of Missouri
Columbia, Missouri, United States
The Ottawa Hospital - Civic Campus
Ottawa, , Canada
University Medical Center Hamburg Eppendorf
Hamburg, , Germany
University Hospital Leipzig
Leipzig, , Germany
University Medical Center Johannes Gutenberg-University
Mainz, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Okayama medical hospital
Okayama, , Japan
University Medical Center Groningen
Groningen, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Cantonal Hospital Lucerne
Lucerne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Gregory Della Rocca
Role: primary
Geoffrey Wilkin
Role: primary
Maximilian Hartel
Role: primary
Philipp Pieroh
Role: primary
Pol Maria Rommens, MD
Role: primary
Daniel Wagners, MD
Role: backup
King Hang Dennis Yee
Role: primary
Naofumi Shiota
Role: primary
Frank IJpma
Role: primary
Matthias Knobe
Role: primary
Other Identifiers
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AOFFP
Identifier Type: -
Identifier Source: org_study_id