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Postoperative Score Predictive of the Prognosis of Acetabular Fractures (SCORE_COTYLE)

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ClinicalTrials.gov Identifier: NCT04626388
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Study Description
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Brief 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 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.

Condition or disease
Acetabular Fracture

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postoperative Score Predictive of the Prognosis of Acetabular Fractures
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : December 9, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Total hip replacement [ Time Frame: Year 2 ]
    This ouctome corresponds to the total hip prosthesis.


Secondary Outcome Measures :
  1. Post-operative complications [ Time Frame: Year 2 ]
    This ouctome corresponds to the postoperative complication rate.

  2. Delay of total hip replacement [ Time Frame: Year 2 ]
    This ouctome corresponds to the delay of total hip replacement.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626388


Contacts
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Contact: Elias MELHEM, MD 1 44 12 76 33 ext +33 emelhem@ghpsj.fr
Contact: Helene BEAUSSIER, PharmD, pHD 144127883 ext +33 crc@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: Elias MELHEM, MD    144127633 ext +33    emelhem@ghpsj.fr   
Contact: Helene BEAUSSIER, pharmD, pHD    144127883 ext +33    crc@ghpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Elias MELHEM, MD Groupe Hospitalier Paris Saint Joseph
More Information
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Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04626388    
Other Study ID Numbers: SCORE_COTYLE
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries