Pelvic FracturePelvFxNCT03476824
Pelvic Fractures in the Elderly
An observational study of Pelvic Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pelvic Fracture
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2006to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pelvic fracture after low-energy trauma
- Treatment in the years 2006 to 2016
- patients equal to or older than 60 years
Who cannot join
- Pelvic fracture after a high-energy space
- Pathological fracture in the area of a tumor or a bony metastasis
- Existence of a documented refusal
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Switzerland, Traumatology
Basel, 4031
About this study
Official title: PelvFx - Pelvic Fractures in the Elderly Patient Influence of Fracture Classification According to Rommens & Hofmann on Mobility, Operation and Independence
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.
- Conditions
- Pelvic Fracture
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
number of patients who died within one year after pelvic fracture
Measured: from pelvic fracture until year 1
loss of independence
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
Measured: from pelvic fracture until year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michaela Ramser, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476824
- Sponsor's protocol ID
- 2017-01859; ch18Ramser
- Other IDs
- 2017
- Acronym
- PelvFx
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PelvFx - Pelvic Fractures in the Elderly Patient Influence of Fracture Classification According to Rommens & Hofmann on Mobility, Operation and Independence
- ClinicalTrials.gov ID
- NCT03476824
- Acronym / sponsor ID
- PelvFx / 2017-01859; ch18Ramser
- Conditions
- Pelvic Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Pelvic fracture after low-energy trauma
- Treatment in the years 2006 to 2016
- patients equal to or older than 60 years
Key exclusion criteria (3 listed)
- Pelvic fracture after a high-energy space
- Pathological fracture in the area of a tumor or a bony metastasis
- Existence of a documented refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: from pelvic fracture until year 1
number of patients who died within one year after pelvic fracture
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Ramser, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: from pelvic fracture until year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.