- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626388
Postoperative Score Predictive of the Prognosis of Acetabular Fractures (SCORE_COTYLE)
September 11, 2023 updated by: Fondation Hôpital Saint-Joseph
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
251
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total hip replacement
Time Frame: Year 2
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This ouctome corresponds to the total hip prosthesis.
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Year 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-operative complications
Time Frame: Year 2
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This ouctome corresponds to the postoperative complication rate.
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Year 2
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Delay of total hip replacement
Time Frame: Year 2
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This ouctome corresponds to the delay of total hip replacement.
|
Year 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elias MELHEM, MD, Fondation Hôpital Saint-Joseph
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Matta 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.
- Verbeek 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.
- Jouffroy 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.
- Verbeek 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2020
Primary Completion (Actual)
January 9, 2023
Study Completion (Actual)
September 11, 2023
Study Registration Dates
First Submitted
November 10, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (Actual)
November 12, 2020
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCORE_COTYLE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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