Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement

Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique600 enrolled

Overview

It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty. The objectives of the study are to: 1. Identify clinical practices set up for patient care 2. Assess the type and the frequency of perioperative complications 3. Look for factors, related to patients or treatments, associated with the occurrence of these complications. The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Postoperative Complications

Interventions

anticoagulationDRUG

anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included

Medical Language ↔ Plain English

Inclusion Criteria: * Adult ≥ 18 years * Programmed for primary hip or knee arthroplasty. * Effective dose of anticoagulant drugs intake for more than 1 month with the intention to resume it after the intervention for ADELC cohort; no effective dose of anticoagulant drugs intake for the control cohort. Exclusion Criteria: * Patient non opposition

Outcomes

Primary Outcomes

a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason

Time frame: up to 3 months

Secondary Outcomes

The length of hospital stay

this is a continuous outcome measured. It measures the number of days from date of entry to the date of hospital discharge

Time frame: until end of study, an expected 12 months

The proportion of patients who are transfused during the hospitalization

Time frame: up to day 15

The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .

Time frame: within 12 months