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Prevention of Ectopic Bone Related Pain and Disability After Hip Replacement Surgery With Peri-Operative Ibuprofen

This study has been completed.
National Health and Medical Research Council, Australia
Medical Benefits Fund Australia Pty Ltd
Information provided by:
The George Institute Identifier:
First received: September 2, 2005
Last updated: November 28, 2006
Last verified: September 2005
The primary aim of this randomised trial is to determine the effects of a short peri-operative course of treatment with a non-steroidal anti-inflammatory drug (NSAID), ibuprofen, on the long-term consequences of ectopic bone formation in patients undergoing elective total hip replacement surgery. The specific hypotheses to be tested at that 6 to 12 months after surgery, patients assigned post-operative ibuprofen will have less self-reported pain and physical disability, greater health-related quality of life and reduced ectopic bone formation compared with those assigned placebo.

Condition Intervention Phase
Osteoarthritis, Hip Arthroplasty, Replacement, Hip Arthritis, Rheumatoid Drug: Ibuprofen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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)

Resource links provided by NLM:

Further study details as provided by The George Institute:

Primary Outcome Measures:
  • Self-reported pain and physical function (WOMAC)

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1000
Study Start Date: February 2002
Estimated Study Completion Date: May 2004
Detailed Description:


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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Patient undergoing elective total hip replacement surgery, or revision thereof -

Exclusion Criteria: A definite indication or contra-indication for treatment with a NSAID during the 14-day study treatment period, in the opinion of the treating clinician.

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Please refer to this study by its identifier: NCT00145730

Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Medical Benefits Fund Australia Pty Ltd
Study Chair: Marlene H Fransen, PhD, MPH The George Institute, University of Sydney
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00145730     History of Changes
Other Study ID Numbers: 153712
Study First Received: September 2, 2005
Last Updated: November 28, 2006

Keywords provided by The George Institute:
osteoarthritis hip
ectopic bone formation
non-steroidal anti-inflammatory drugs

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Cardiac Complexes, Premature
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017