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

Arthritis, Rheumatoid Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145730
• Other study ID #: 153712
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: November 28, 2006
• Start date: February 2002
• Est. completion date: May 2004

Study information

• Verified date: September 2005
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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. 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.

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treatment period, unless such treatment becomes definitely indicated, in which case the study treatment should be withdrawn and open label treatment provided.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Arthroplasty, Replacement, Hip
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• Ibuprofen

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The George Institute	Medical Benefits Fund Australia Pty Ltd, National Health and Medical Research Council, Australia

References & Publications (2)

Fransen 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 ectop — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain and physical function (WOMAC)
Secondary	Health-related quality of life (SF36v2)
Secondary	Patients' global assessment
Secondary	Physical performance measures: hip flexion, 50ft walk time, up and go.
Secondary	Major bleeding events: bleeding from wound > 3 days, evacuation of wound hematoma, hematemesis, melaena, other.

External Links

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