Acetabular FractureNCT03478189
The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction
An observational study of Acetabular Fracture and Acetabular Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture, Acetabular Surgery
- What is being tested?
- use of O-arm surgical imaging
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2017to 31 Dec 2019
- 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 hospitalized in GHPSJ from april 2016 and october 2017
Who may be able to join
- age> 18
- surgery for acetabular fracture within 30 days
- with dome impaction
Who cannot join
- disability of inferior limb
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
The acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation.
The presence of dome impaction makes the surgery more difficult. Per operatory scanner associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study is show that this association permit a technical improvement for the surgeon in the precision of fracture reduction.and restore the articular congruence.
- Conditions
- Acetabular Fracture, Acetabular Surgery
- Being tested
- use of O-arm surgical imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of O-arm surgical imagingProcedure or surgery
during acetabular fracture surgery , use of O-arm surgical imaging with
What is being measured
The primary outcome is the main question the study is designed to answer.
dome impaction reduction measurement
dome impaction reduction measurement on scanner per operatory and post operatory
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume RIOUALLON, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478189
- Sponsor's protocol ID
- OARM impactionTOIT
- Status last verified
- Feb 2020
- First submitted
- 19 Mar 2018
- Last updated
- 5 Feb 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction
- ClinicalTrials.gov ID
- NCT03478189
- Acronym / sponsor ID
- OARM impactionTOIT
- Conditions
- Acetabular Fracture, Acetabular Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 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 acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation.
The presence of dome impaction makes the surgery more difficult. Per operatory scanner associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study is show that this association permit a technical improvement for the surgeon in the precision of fracture reduction.and restore the articular congruence.
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 hospitalized in GHPSJ from april 2016 and october 2017
Key inclusion criteria (3 listed)
- age> 18
- surgery for acetabular fracture within 30 days
- with dome impaction
Key exclusion criteria (1 listed)
- disability of inferior limb
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 |
|---|---|---|
| use of O-arm surgical imagingduring acetabular fracture surgery , use of O-arm surgical imaging with | Procedure or surgery | – |
Primary outcome
dome impaction reduction measurement
Time frame: day1
dome impaction reduction measurement on scanner per operatory and post operatory
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 5 Feb 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.
Guillaume RIOUALLON, MD principal investigator
Fondation Hôpital Saint-Joseph
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 and Acetabular Surgery, 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 5 Feb 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 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?
dome impaction reduction measurement (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 5 Feb 2020.