ElderlyjantjeVLNCT03581669
Acetabular Cerclage and Total Hip Arthroplasty in the Treatment of Acetabular Fractures in Elderly Patients.
An observational study of Elderly and Acetabular Fractures, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
We want to present the outcome of complex multifragmented acetabular fractures in the elderly treated with acetabular cerclage and total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Acetabular Fractures, Cerclage Acetabular Fractures
- What is being tested?
- Cerclage and total hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: elderly patients who sustained an acetabular fracture
Who may be able to join
- elderly (>60Years)
- acetabular fracture
Who cannot join
- Revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
We want to present the outcome of complex multifragmented acetabular fractures in the elderly treated with acetabular cerclage and total hip arthroplasty.
- Being tested
- Cerclage and total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerclage and total hip arthroplastyDevice
acetabular fractures in the elderly treated with cerclage acetabulum and total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| THA + cerclage acetabulum | Not described Receives: Device: Cerclage and total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
harris hip score
outcome after cerclage and THA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study startAug 2014 (estimated)
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanderschot Paul, MD, Phd, Principal investigator, UZ LeuvenMolenaers Guy, MD, Phd, Study chair, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581669
- Sponsor's protocol ID
- BJCerTHA
- Other IDs
- UZ leuven
- Acronym
- jantjeVL
- Status last verified
- Mar 2021
- First submitted
- 26 Jun 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mouhsine E, Garofalo R, Borens O, Blanc CH, Wettstein M, Leyvraz PF. Cable fixation and early total hip arthroplasty in the treatment of acetabular fractures in elderly patients. J Arthroplasty. 2004 Apr;19(3):344-8. doi: 10.1016/j.arth.2003.08.020.
PubMed 15067649
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetabular Cerclage and Total Hip Arthroplasty in the Treatment of Acetabular Fractures in Elderly Patients.
- ClinicalTrials.gov ID
- NCT03581669
- Acronym / sponsor ID
- jantjeVL / BJCerTHA
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2014 (estimated)
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 10 Jul 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.
We want to present the outcome of complex multifragmented acetabular fractures in the elderly treated with acetabular cerclage and total hip arthroplasty.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THA + cerclage acetabulum | – | Device: Cerclage and total hip arthroplasty |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients who sustained an acetabular fracture
Key inclusion criteria (2 listed)
- elderly (>60Years)
- acetabular fracture
Key exclusion criteria (1 listed)
- Revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerclage and total hip arthroplastyacetabular fractures in the elderly treated with cerclage acetabulum and total hip arthroplasty | Device | THA + cerclage acetabulum |
Primary outcome
harris hip score
Time frame: 1 year
outcome after cerclage and THA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Background: PubMed 15067649Mouhsine E, Garofalo R, Borens O, Blanc CH, Wettstein M, Leyvraz PF. Cable fixation and early total hip arthroplasty in the treatment of acetabular fractures in elderly patients. J Arthroplasty. 2004 Apr;19(3):344-8. doi: 10.1016/j.arth.2003.08.020.
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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.
Vanderschot Paul, MD, Phd principal investigator
UZ Leuven
Molenaers Guy, MD, Phd study chair
UZ Leuven
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 Elderly and Acetabular Fractures, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Mar 2021. 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 Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
harris hip score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581669, which also lists 1 linked publication.
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 2 Mar 2021.