Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145730
Status:
COMPLETED
Last Update Posted:
2006-11-29
First Post:
2005-09-02
Brief Title:
Prevention of Ectopic Bone Related Pain and Disability After Hip Replacement Surgery With Peri-Operative Ibuprofen
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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14-day treatment period unless such treatment becomes definitely indicated in which case the study treatment should be withdrawn and open label treatment provided There will be no other changes to standard care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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None