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.
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)
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.
Single group
Thrombotic risk assessment
Other interventionCollection of symptomatic thrombotic events occurring during the 5 days of hospitalization and then by telephone interview at M1 +/- 3 days. Complete echodoppler (proximal and distal) performed at M1 to highlight asymptomatic thrombotic events.
Area under the Receiver Operating Characteristic curve
To assess the prognostic value of the microvesicle-dependent coagulolytic balance measured after D0 surgery (pre-administration of prophylactic treatment) in the occurrence of a post-total knee replacement thrombotic event (distal or proximal).
Best prognostic threshold of MV coagulolytic balance measured
Maximize sensitivity and specificity (Youden's method), and intrinsic and extrinsic performances associated with the threshold: sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value, with their 95% confidence intervals.
Estimation of the area under the ROC curve with its 95% confidence interval - The procoagulant activity of MV is dependent on FT
To assess the overall prognostic value of FT-dependent MV procoagulant activity at D0 (pre- and post-surgery) and D3, for the occurrence of a symptomatic or asymptomatic thrombotic event at 1 month post-PTG, the best prognostic threshold, and the intrinsic and extrinsic performance associated with the determined threshold, together with their 95% confidence intervals
Estimation of the area under the ROC curve with its 95% confidence interval - Fibrinolytic activity of MV
Allows assessment of the overall prognostic value of MV fibrinolytic activity at D0 (pre- and post-surgery) and D3, for the occurrence of a symptomatic or asymptomatic thrombotic event at 1 month post-PTG, best prognostic threshold, and intrinsic and extrinsic performance associated with the determined threshold, together with their 95% confidence interval.
Estimation of the area under the ROC curve with its 95% confidence interval - Coagulolytic balance of MV
Allows assessment of the prognostic value of the coagulolytic balance of MVs at D0 (before and after surgery) and D3, for the occurrence of a symptomatic thrombotic event (pulmonary embolism or DVT) at 1 month post-PTG, the best prognostic threshold, and the intrinsic and extrinsic performances associated with the determined threshold, together with their 95% confidence interval
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
