Acetabulum FractureNCT03040739
Treatment of Acetabulum Fracture With O'ARM Surgical Imaging
An observational study of Acetabulum Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabulum Fracture
- What is being tested?
- use of O'ARM imaging system
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2016to 15 Jun 2017
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Every patients admitted in the service of orthopaedic surgery for fracture of the cotyle
Who may be able to join
- Age >18 years
- acetabulum fracture dating less than a month
Who cannot join
- No exclusion criteria
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
Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. So surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .
The aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface
- Conditions
- Acetabulum Fracture
- Being tested
- use of O'ARM imaging system
- Keywords
- O'ARM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of O'ARM imaging systemOther
use of O'ARM imaging system
| Study group | Role | What they receive |
|---|---|---|
| case | Not described Receives: Other: use of O'ARM imaging system | |
| control | Not described Receives: Other: use of O'ARM imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of incongruity
Reduction of the articular surface of the acetabulum
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start8 Jul 2016
- Primary completion1 Jan 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabulum 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040739
- Sponsor's protocol ID
- COTYLE_O'ARM
- Status last verified
- Sep 2017
- First submitted
- 31 Jan 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acetabulum Fracture With O'ARM Surgical Imaging
- ClinicalTrials.gov ID
- NCT03040739
- Acronym / sponsor ID
- COTYLE_O'ARM
- Conditions
- Acetabulum Fracture
- Keywords
- O'ARM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 2 Feb 2017 (estimated)
- 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.
Acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. This fracture generates an incongruity between acetabulum and femoral head. So surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.Navigation is widely used in orthopaedic surgery .
The aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: use of O'ARM imaging system |
| control | – | Other: use of O'ARM imaging system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patients admitted in the service of orthopaedic surgery for fracture of the cotyle
Key inclusion criteria (2 listed)
- Age >18 years
- acetabulum fracture dating less than a month
Key exclusion criteria (1 listed)
- No exclusion criteria
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 imaging systemuse of O'ARM imaging system | Other | case, control |
Primary outcome
Height of incongruity
Time frame: Day 1
Reduction of the articular surface of the acetabulum
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 6 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acetabulum 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 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: finished, as of the sponsor's last update on 6 Sep 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?
Height of incongruity (time frame: Day 1). 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 6 Sep 2017.