Status:
NOT_YET_RECRUITING
Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery.
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Knee Prosthesis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a prospective multicenter cohort study to evaluate the prognostic value of new biological markers in predicting thrombotic events after orthopedic surgery. According to the inclusion and non-i...
Detailed Description
Recruitment and follow-up of patients will be carried out in 3 hospitals by the respective orthopedic teams. Three hundred and eighty-seven patients will be included in the study, over a period of 36 ...
Eligibility Criteria
Inclusion
- Subject, male or female, aged 18 to 85 years (upper age limit classically used in the literature of PTG79-81)
- First-line TKP (knee native to any prosthesis) performed to treat primary or secondary osteoarthritis.
- In case of contralateral PTG, a delay of 12 months between the 2 prostheses will be respected according to the habits of the inclusion centers.
- ASA score \<4 (American Society of Anesthesiologists)
- No contraindication to prophylactic treatment with low molecular weight heparin (LMWH)
- Subject not taking anticoagulant or antiaggregant therapy at therapeutic dose
- Subject who has signed the informed consent form
- Subject affiliated to the social security system
Exclusion
- Subjects with a history of sepsis, tumor or trauma in the considered joint
- Subject with sepsis or acute infection
- Immunocompromised subject (HIV, transplant, chemotherapy, leukemia, glucocorticoids \>3 months)
- Subjects with severe respiratory, circulatory or cardiac pathologies involving anticoagulant treatment likely to influence the coagulolytic balance.
- Subject with severe renal insufficiency (creatinine clearance \< 30ml/min)
- Subject refusing to participate in the study or not signing the informed consent or unable to adhere to the study procedures
- Subjects who are minors, pregnant or breastfeeding, not affiliated with the social security system, or deprived of liberty
- Subject already included in an interventional trial (which may alter the results of that study)
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT05387694
Start Date
June 1 2023
End Date
December 1 2026
Last Update
April 21 2023
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, Bouches Du Rhône, France, 13354