Acetabular FractureACETANCT03929536
Treatment of Acetabular Fractures in Elderly Patients
An observational study of Acetabular Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acetabular Fracture
- How many people
- 211 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Mar 2019to 2 Jun 2020
- 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: patients with acetabular fracture between 2009 and 2018 treated at the Department of Orthopedic and Trauma Surgery of University Hospital Basel
Who may be able to join
- surgical treatment of acetabular fracture between 2009 and 2018
Who cannot join
- pathological fractures due to neoplasm or metastasis
- status after implantation of an endoprosthesis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Trauma Surgery (DOTS).
Basel, 4031
About this study
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.
- Conditions
- Acetabular Fracture
- Keywords
- hip joint replacement, hip joint preserving surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in living arrangements
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)
Measured: at baseline (right after surgery) and 1 year after surgery
Secondary outcomes (5)
number of rehospitalisations
number of rehospitalisations
Measured: single time point assessment 1 year after surgery
number of re-surgeries
number of re-surgeries
Measured: single time point assessment 1 year after surgery
mortality
number of deaths
Measured: single time point assessment 1 year after surgery
infections
number and type of infections
Measured: single time point assessment 1 year after surgery
Change in leg length difference
radiological leg length difference (mm)
Measured: at baseline (right after surgery) and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start27 Mar 2019
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franziska Saxer, Dr. med, Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929536
- Sponsor's protocol ID
- 2019-00520; ch19Saxer2
- Other IDs
- 2019
- Acronym
- ACETA
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2019
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acetabular Fractures in Elderly Patients
- ClinicalTrials.gov ID
- NCT03929536
- Acronym / sponsor ID
- ACETA / 2019-00520; ch19Saxer2
- Conditions
- Acetabular Fracture
- Keywords
- hip joint replacement, hip joint preserving surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 29 Apr 2019 (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.
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 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
- patients with acetabular fracture between 2009 and 2018 treated at the Department of Orthopedic and Trauma Surgery of University Hospital Basel
Key inclusion criteria (1 listed)
- surgical treatment of acetabular fracture between 2009 and 2018
Key exclusion criteria (2 listed)
- pathological fractures due to neoplasm or metastasis
- status after implantation of an endoprosthesis
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
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)
5 secondary outcomes
number of rehospitalisations
Time frame: single time point assessment 1 year after surgery
number of re-surgeries
Time frame: single time point assessment 1 year after surgery
mortality
Time frame: single time point assessment 1 year after surgery
infections
Time frame: single time point assessment 1 year after surgery
Change in leg length difference
Time frame: at baseline (right after surgery) and 1 year after surgery
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 4 Jun 2020.
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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.
Franziska Saxer, Dr. med principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
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 Acetabular 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 1 inclusion and 2 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 4 Jun 2020. 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?
Change in living arrangements (time frame: at baseline (right after surgery) and 1 year after surgery). 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 4 Jun 2020.