Osteoarthritis, HipPhase 4NCT00145730
Prevention of Ectopic Bone Related Pain and Disability After Hip Replacement Surgery With Peri-Operative Ibuprofen
A Phase 4 study testing Ibuprofen in people with Osteoarthritis, Hip and Arthroplasty, Replacement, Hip, run by The George Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip, Arthroplasty, Replacement, Hip, Arthritis, Rheumatoid
- What is being tested?
- Ibuprofen
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to May 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
-
About this study
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)
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.
Read the detailed description
Methodology:
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.
Participants:
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:
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.
Outcomes:
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.
- Being tested
- Ibuprofen
- Keywords
- osteoarthritis hip, arthroplasty, ectopic bone formation, non-steroidal anti-inflammatory drugs, disability
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain and physical function (WOMAC)
Secondary outcomes (4)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Medical Benefits Fund Australia Pty Ltd
- Investigators
- Marlene H Fransen, PhD, MPH, Study chair, The George Institute, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145730
- Sponsor's protocol ID
- 153712
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 29 Nov 2006
- Results posted
- No
Publications
Fransen M; HIPAID Management Committee of the HIPAID Collaborative Group. Preventing chronic ectopic bone-related pain and disability after hip replacement surgery with perioperative ibuprofen. A multicenter, randomized, double-blind, placebo-controlled trial (HIPAID). Control Clin Trials. 2004 Apr;25(2):223-33. doi: 10.1016/j.cct.2003.11.008.
PubMed 15020038Fransen M, Anderson C, Douglas J, MacMahon S, Neal B, Norton R, Woodward M, Cameron ID, Crawford R, Lo SK, Tregonning G, Windolf M; HIPAID Collaborative Group. Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial. BMJ. 2006 Sep 9;333(7567):519. doi: 10.1136/bmj.38925.471146.4F. Epub 2006 Aug 2.
PubMed 16885182Fransen M, Neal B, Cameron ID, Crawford R, Tregonning G, Winstanley J, Norton R; HIPAID Collaborative Group. Determinants of heterotopic ossification after total hip replacement surgery. Hip Int. 2009 Jan-Mar;19(1):41-6. doi: 10.1177/112070000901900108.
PubMed 19455501
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00145730
- Acronym / sponsor ID
- 153712
- Keywords
- osteoarthritis hip, arthroplasty, ectopic bone formation, non-steroidal anti-inflammatory drugs, disability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Medical Benefits Fund Australia Pty Ltd
- Study start
- Feb 2002
- Study completion
- May 2004
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methodology:
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.
Participants:
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:
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.
Outcomes:
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen | Drug | – |
Primary outcome
Self-reported pain and physical function (WOMAC)
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2006.
- Background: PubMed 15020038Fransen M; HIPAID Management Committee of the HIPAID Collaborative Group. Preventing chronic ectopic bone-related pain and disability after hip replacement surgery with perioperative ibuprofen. A multicenter, randomized, double-blind, placebo-controlled trial (HIPAID). Control Clin Trials. 2004 Apr;25(2):223-33. doi: 10.1016/j.cct.2003.11.008.
- Results publication: PubMed 16885182Fransen M, Anderson C, Douglas J, MacMahon S, Neal B, Norton R, Woodward M, Cameron ID, Crawford R, Lo SK, Tregonning G, Windolf M; HIPAID Collaborative Group. Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial. BMJ. 2006 Sep 9;333(7567):519. doi: 10.1136/bmj.38925.471146.4F. Epub 2006 Aug 2.
- Derived from this study: PubMed 19455501Fransen M, Neal B, Cameron ID, Crawford R, Tregonning G, Winstanley J, Norton R; HIPAID Collaborative Group. Determinants of heterotopic ossification after total hip replacement surgery. Hip Int. 2009 Jan-Mar;19(1):41-6. doi: 10.1177/112070000901900108.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene H Fransen, PhD, MPH study chair
The George Institute, University of Sydney
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen in people with Osteoarthritis, Hip and Arthroplasty, Replacement, Hip, run by The George Institute.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain and physical function (WOMAC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145730, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2006.