Postoperative Complications
Conditions
Brief summary
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.
Interventions
DRUGanticoagulation
anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included
Sponsors
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason | up to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The length of hospital stay | until end of study, an expected 12 months | this is a continuous outcome measured. It measures the number of days from date of entry to the date of hospital discharge |
| The proportion of patients who are transfused during the hospitalization | up to day 15 | — |
| The occurrence of a complication of grade 2 or more from Dindo and Clavien classification . | within 12 months | — |
Countries
France
Outcome results
None listed