Patients undergoing elective unilateral primary hip arthroplasty, who fulfil the criteria for a fast-track protocol including early mobilization and discharge from the hospital after surgery.
Conditions
Brief summary
Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial
Detailed description
Death from any cause, isolated symptomatic distal DVT, myocardial infarction or stroke, need for readmission to the hospital and length of hospital stay;, serious adverse events (SAEs), patient mobility, changes in patientreported hip joint-specific disability following surgery, generic quality of life, postoperative healthcare resource utilization within the first 35 days after surgery, Overt major or clinically relevant non-major bleeding
Interventions
DRUGRivaroxaban
DRUGPlacebo hard capsules were manufactured from P-tablets (P-Tabletten weiß 7 mm Lichtenstein®
DRUGZulassungs-Nr. 6866372.00.00).
For further information see SmPC
Sponsors
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation in another interventional clinical trial at inclusion or within the last 30 days prior to inclusion, except during the observational follow-up period of that other trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Death from any cause, isolated symptomatic distal DVT, myocardial infarction or stroke, need for readmission to the hospital and length of hospital stay;, serious adverse events (SAEs), patient mobility, changes in patientreported hip joint-specific disability following surgery, generic quality of life, postoperative healthcare resource utilization within the first 35 days after surgery, Overt major or clinically relevant non-major bleeding | — |
Countries
Austria, Germany
Outcome results
None listed