Acetabular FractureNCT03312491
Treatment of Acetabular Fracture: the Contribution of the 3D Impression
An observational study of Acetabular Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Acetabular fracture are common in elder patients and high energy trauma in younger one. However, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. Anatomic reduction and osteosynthesis of these fracture are technically difficult . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2016to 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patient admitted in orthopaedic yard for acetabulum fracture
Who may be able to join
- age >18
- acetabulum fracture within one month
- anterior access or double access
Who cannot join
- acetabulum fracture more than one month
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Acetabular fracture are common in elder patients and high energy trauma in younger one.
However, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. Anatomic reduction and osteosynthesis of these fracture are technically difficult .
3D printing ease the process of operating planification or implant fabrication. The 3D impression allows to obtain a model on the scale of the pond of the patient allowing to pre mold plates on the anatomy of the patient before he is operated with the aim of decreasing the surgical time and improving the quality of the reduction.
- Conditions
- Acetabular Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
operating room time
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start22 Aug 2016
- 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 Acetabular 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pomme JOUFFROY, MD, Study chair, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312491
- Sponsor's protocol ID
- 3D COTYLE
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acetabular Fracture: the Contribution of the 3D Impression
- ClinicalTrials.gov ID
- NCT03312491
- Acronym / sponsor ID
- 3D COTYLE
- Conditions
- Acetabular Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Oct 2017 (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.
Acetabular fracture are common in elder patients and high energy trauma in younger one.
However, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. Anatomic reduction and osteosynthesis of these fracture are technically difficult .
3D printing ease the process of operating planification or implant fabrication. The 3D impression allows to obtain a model on the scale of the pond of the patient allowing to pre mold plates on the anatomy of the patient before he is operated with the aim of decreasing the surgical time and improving the quality of the reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient admitted in orthopaedic yard for acetabulum fracture
Key inclusion criteria (3 listed)
- age >18
- acetabulum fracture within one month
- anterior access or double access
Key exclusion criteria (1 listed)
- acetabulum fracture more than one month
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
operating room time
Time frame: day1
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 17 Oct 2017.
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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.
Pomme JOUFFROY, MD study chair
GHPSJ
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 Fondation Hôpital Saint-Joseph at 1 site in France.
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 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: finished, as of the sponsor's last update on 17 Oct 2017. 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 France. 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?
operating room time (time frame: day1). 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 17 Oct 2017.