- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03929536
Treatment of Acetabular Fractures in Elderly Patients (ACETA)
June 2, 2020 updated by: University Hospital, Basel, Switzerland
This retrospective study investigates surgical treatment of acetabular fractures in elderly patients (>60 years of age), either undergoing joint-preserving surgery or joint- replacement. 1 year- outcome with regard to mobility and autonomy is assessed.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4031
- Department of Orthopaedics and Trauma Surgery (DOTS).
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
56 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with acetabular fracture between 2009 and 2018 treated at the Department of Orthopedic and Trauma Surgery of University Hospital Basel
Description
Inclusion Criteria:
- surgical treatment of acetabular fracture between 2009 and 2018
Exclusion Criteria:
- pathological fractures due to neoplasm or metastasis
- status after implantation of an endoprosthesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in living arrangements
Time Frame: at baseline (right after surgery) and 1 year after surgery
|
preservation of autonomy investigated by assessment of living arrangements: at home (by oneself, with a partner, with professional support), residential home for the elderly with occasional support, nursing home)
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at baseline (right after surgery) and 1 year after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of rehospitalisations
Time Frame: single time point assessment 1 year after surgery
|
number of rehospitalisations
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single time point assessment 1 year after surgery
|
|
number of re-surgeries
Time Frame: single time point assessment 1 year after surgery
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number of re-surgeries
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single time point assessment 1 year after surgery
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mortality
Time Frame: single time point assessment 1 year after surgery
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number of deaths
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single time point assessment 1 year after surgery
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infections
Time Frame: single time point assessment 1 year after surgery
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number and type of infections
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single time point assessment 1 year after surgery
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Change in leg length difference
Time Frame: at baseline (right after surgery) and 1 year after surgery
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radiological leg length difference (mm)
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at baseline (right after surgery) and 1 year after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Franziska Saxer, Dr. med, Department of Orthopaedics and Traumatology, University Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2019
Primary Completion (Actual)
June 2, 2020
Study Completion (Actual)
June 2, 2020
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 24, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 2, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00520; ch19Saxer2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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