Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT05387694
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05387694
Study Brief:
Protocol Section:
NCT05387694