Coxarthrosis | Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty
Coxarthrosis research study
What is the primary objective of this study?
The primary aim of this study is to test if etoricoxib decreases the perioperative blood loss compared to diclofenac. Secondary questions to be explored are: - Does etoricoxib prevent Heterotopic ossification after Total Hip Arthroplasty as well as diclofenac ? - Do diclofenac and etoricoxib both reduce pain at rest and on movements? - Does etoricoxib compared to diclofenac reduce the amount of rescue medication (Oxycodon)? - Does etoricoxib improve gastrointestinal tolerability compared to diclofenac?
Who is eligible to participate?
Inclusion Criteria: - Indication for THA because of primary and secondary osteoarthritis of the hip. - male or female patients of the age of 55 - 85 years - informed consent afer having been informed in detail about the clinical trial by the investigator - negative pregnancy test (<= 2 days before inclusion) for women with child bearing potential (pre menopausal, <2 years menopausal, not surgically sterile), use of high security contraception methods as oral contraception agents or preservatives. The use of high security conception methods is also to obligatory for male patients Exclusion Criteria: - Known hypersensitivity to one of the two investigational medical products or substaces of similar chemical structure or to any of the excipients - Patients who have experienced bronchospasm, asthma, acute rhinitis, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors - unexplained dysfunction of haematopoiesis - treatment with NSAIDs or coxiben in the past 5 days before start of study - Active peptic ulceration or active gastro-intestinal (GI) bleeding - Pregnancy and lactation - Congestive heart failure (NYHA II-IV) - Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease - clinically relevant disease of the cardiovascular system, severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10), severe renal dysfunction (estimated renal creatinine clearance <30 ml/min, clinical relevant disease of the nervous system, the endocrinium or another severe systematic disease - Systemic lupus erythematodes or mixed connective tissue disease - Inflammatory bowel disease - alcohol or drug abuse during the last past 3 months - Patients with hypertension BP persistently > 140/90mmHG) and has not been adequately controlled - life expectancy <6 months - state of mind which does not enable the patient to understand the nature of the study, its importance and possible consequences - evidence that the respective person will not cooperate with the study protocoll - participation of the patient in another clinical trial during the past 4 weeks before inclusion - prior participation in this clinical trial
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Arthroplasties Hip Replacement
Perioperative Blood Loss
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EtoricoxibArcoxia 90 mg once a day in the evening day -1 and 0 and once a day in the morning days 1-7 plus on tablett of placebo every evening
Drug:DiclofenacVoltaren Resinat 75mg once a day on day -1 and 0 in the evening; twice a day (in the morning and in the evening) days 1-7
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: February 2011
Completed Date: August 2014
Phase: Phase 3
Primary Outcome: Perioperative blood loss after implantation of a hip joint endoprosthesis
Secondary Outcome: Heterotopic ossification
Study sponsors, principal investigator, and references
Lead Sponsor: University of Regensburg