Status:
COMPLETED
Efficacy Study of Pre-emptive Etoricoxib for Postoperative Pain and Functional Outcome in Total Knee Arthroplasty
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to study the efficacy of pre-emptive etoricoxib in reducing post-operative pain and improving function outcome after a total knee arthroplasty.
Detailed Description
Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic surgeries worldwide and has proven to be a success in the treatment of end-stage osteoarthritic knees. TKA is associated...
Eligibility Criteria
Inclusion
- Patients between the ages of 50 and 80 who are listed for single-knee TKA at Singapore General Hospital by one of 4 adult reconstructive surgeons for the treatment of osteoarthritis will be recruited upon the patient giving written informed consent.
Exclusion
- \- Younger than 50, older than 80
- Known allergy to etoricoxib or other cycloxygenase-2 inhibitors, aspirin or any Non-steroidal Anti-inflammatory Drugs (NSAIDs)
- American Society of Anaesthesiologists (ASA) grade IV
- Renal insufficiency (Creatinine \> 110)
- Known coagulation or hepatic disorder
- Inflammatory arthritis
- Inflammatory bowel disease
- Concurrent conditions which would affect interpretation of pain eg spinal stenosis, lumbar nerve root impingement
- Depression or usage of opioids, sedatives or hypnotics preoperatively
- Special classes of subjects including those pregnant, cognitively impaired, prisoners or institutionalized patients
- Patients with clinically significant abnormalities of laboratory safety tests at baseline, or a history of significant clinical or laboratory abnormality that in the opinion of the investigator would contraindicate the use of etoricoxib
- Patients with unstable hypertension, uncontrolled diabetes mellitus, New York Heart Association (NYHA) class II-IV congestive heart failure, ischaemic heart disease, cerebrovascular disease or peripheral vascular disease (including patients who have recently undergone coronary artery bypass graft of angioplasty)
- Patients with active gastric ulceration or gastrointestinal bleeding
- Patients with a history of any illness that in the opinion of the investigator may confound the results of the study or pose additional risks to the patient
- Occurrence of any surgical complication would exclude the patient from analysis
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01246362
Start Date
July 1 2011
End Date
January 1 2014
Last Update
February 10 2017
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, Singapore, 169608