Prevention of Ectopic Bone Related Pain and Disability After Hip Replacement Surgery With Peri-Operative Ibuprofen
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00145730|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : November 29, 2006
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip Arthroplasty, Replacement, Hip Arthritis, Rheumatoid||Drug: Ibuprofen||Phase 4|
The study is a multicentre, randomised, double blind, placebo-controlled trial. 1000 patients undergoing elective total hip replacement surgery from 20 orthopaedic centres in Australia and New Zealand will be assigned to receive either ibuprofen (1200mg daily) or matching placebo in 3 divided doses for 14 days. Study treatment will be started postoperatively on the day of surgery. Patient should not receive any other NSAIDs, apart from low dose aspirin, during the 14-day treatment period, unless such treatment becomes definitely indicated, in which case the study treatment should be withdrawn and open label treatment provided. There will be no other changes to standard care.
All patient scheduled for elective total hip replacement surgery, or revision thereof, are potentially eligible unless there is a definite indication for or contraindication to treatment with a NSAID during the 14-day treatment period.
Randomisation will be performed centrally using a computer-based system that can be accessed 24 hours a day by a toll-free telephone call. A minimisation program will stratify treatment allocation by centre.
The primary outcome are self-reported pain and physical function, 6 to 12 months after randomisation. Secondary outcomes include health-related quality of life, patients' global assessment, radiographic evidence of ectopic bone.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicentre Randomised Placebo-Controlled Trail of Ibuprofen for the Prevention of Ectopic Bone-Related Pain and Disability After Elective Hip Replacement Surgery (HIPAID)|
|Study Start Date :||February 2002|
|Study Completion Date :||May 2004|
- Self-reported pain and physical function (WOMAC)
- Health-related quality of life (SF36v2)
- Patients' global assessment
- Physical performance measures: hip flexion, 50ft walk time, up and go.
- Major bleeding events: bleeding from wound > 3 days, evacuation of wound hematoma, hematemesis, melaena, other.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145730
|Study Chair:||Marlene H Fransen, PhD, MPH||The George Institute, University of Sydney|