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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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-inclusion criteria below, the study will include 387 major subjects who will undergo first-line total knee replacement and will receive the same standard prophylactic treatment: anticoagulation with Lovenox® (enoxaparin) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings.

Eligibility criteria

Qualifiers

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.

ASA score <4 (American Society of Anesthesiologists)

No contraindication to prophylactic treatment with low molecular weight heparin (LMWH)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Thrombotic risk assessment

Treatment groups

387 Participants
are divided into 1 treatment group