Acetabular FractureSCORE_COTYLENCT04626388
Postoperative Score Predictive of the Prognosis of Acetabular Fractures
An observational study of Acetabular Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- How many people
- 251 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2020to 11 Sep 2023
- 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: The patients were operated on for an acetabulum fracture within the Paris Saint Joseph Hospital Group, between January 2004 and December 2014, with a minimum post-operative follow-up of 2 years.
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient operated on for an acetabular fracture at the GHPSJ between January 2004 and December 2014
- Patient with a minimum postoperative follow-up of 2 years
- French-speaking patient
Who cannot join
- Patient treated conservatively.
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of his medical data as part of this study
Trial locations and contacts
1 site in 1 country.
About this study
Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.
- Conditions
- Acetabular Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hip replacement
This ouctome corresponds to the total hip prosthesis.
Measured: Year 2
Secondary outcomes (2)
Post-operative complications
This ouctome corresponds to the postoperative complication rate.
Measured: Year 2
Delay of total hip replacement
This ouctome corresponds to the delay of total hip replacement.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start9 Dec 2020
- Primary completion9 Jan 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias MELHEM, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626388
- Sponsor's protocol ID
- SCORE_COTYLE
- Acronym
- SCORE_COTYLE
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matta JM, Mehne DK, Roffi R. Fractures of the acetabulum. Early results of a prospective study. Clin Orthop Relat Res. 1986 Apr;(205):241-50.
PubMed 3698383Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.
PubMed 8934477Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.
PubMed 29040129Jouffroy P, Sebaaly A, Aubert T, Riouallon G. Improved acetabular fracture diagnosis after training in a CT-based method. Orthop Traumatol Surg Res. 2017 May;103(3):325-329. doi: 10.1016/j.otsr.2016.10.020. Epub 2016 Dec 23.
PubMed 28017876Verbeek DO, van der List JP, Moloney GB, Wellman DS, Helfet DL. Assessing Postoperative Reduction After Acetabular Fracture Surgery: A Standardized Digital Computed Tomography-Based Method. J Orthop Trauma. 2018 Jul;32(7):e284-e288. doi: 10.1097/BOT.0000000000001161.
PubMed 29481491
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Score Predictive of the Prognosis of Acetabular Fractures
- ClinicalTrials.gov ID
- NCT04626388
- Acronym / sponsor ID
- SCORE_COTYLE / SCORE_COTYLE
- Conditions
- Acetabular Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 12 Nov 2020 (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.
Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients were operated on for an acetabulum fracture within the Paris Saint Joseph Hospital Group, between January 2004 and December 2014, with a minimum post-operative follow-up of 2 years.
Key inclusion criteria (4 listed)
- Patient whose age is ≥ 18 years
- Patient operated on for an acetabular fracture at the GHPSJ between January 2004 and December 2014
- Patient with a minimum postoperative follow-up of 2 years
- French-speaking patient
Key exclusion criteria (5 listed)
- Patient treated conservatively.
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of his medical data as part of this study
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
Total hip replacement
Time frame: Year 2
This ouctome corresponds to the total hip prosthesis.
2 secondary outcomes
Post-operative complications
Time frame: Year 2
Delay of total hip replacement
Time frame: Year 2
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 13 Sep 2023.
- Results publication: PubMed 3698383Matta JM, Mehne DK, Roffi R. Fractures of the acetabulum. Early results of a prospective study. Clin Orthop Relat Res. 1986 Apr;(205):241-50.
- Results publication: PubMed 8934477Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.
- Results publication: PubMed 29040129Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.
- Results publication: PubMed 28017876Jouffroy P, Sebaaly A, Aubert T, Riouallon G. Improved acetabular fracture diagnosis after training in a CT-based method. Orthop Traumatol Surg Res. 2017 May;103(3):325-329. doi: 10.1016/j.otsr.2016.10.020. Epub 2016 Dec 23.
- Results publication: PubMed 29481491Verbeek DO, van der List JP, Moloney GB, Wellman DS, Helfet DL. Assessing Postoperative Reduction After Acetabular Fracture Surgery: A Standardized Digital Computed Tomography-Based Method. J Orthop Trauma. 2018 Jul;32(7):e284-e288. doi: 10.1097/BOT.0000000000001161.
Related trials for Acetabular Fracture
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Active, not recruitingPhase 2
Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum
RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
Recruiting
Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
Acetabular Fractures
Not yet recruitingObservational study
Functional and Radiological Outcomes of Pediatric Acetabular Fracture Management
Acetabular Fractures in Pediatrics
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.
Elias MELHEM, 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, 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 4 inclusion and 5 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 13 Sep 2023. 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?
Total hip replacement (time frame: Year 2). 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 NCT04626388, which also lists 5 linked publications.
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 13 Sep 2023.