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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2004-05-31

Brief Summary

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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

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treatment period, unless such treatment becomes definitely indicated, in which case the study treatment should be withdrawn and open label treatment provided.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

Conditions

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Osteoarthritis, Hip Arthroplasty, Replacement, Hip Arthritis, Rheumatoid

Keywords

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osteoarthritis hip arthroplasty ectopic bone formation non-steroidal anti-inflammatory drugs disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Marlene H Fransen, PhD, MPH

Role: STUDY_CHAIR

The George Institute, University of Sydney

References

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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.

Reference Type BACKGROUND

PMID: 15020038 (View on PubMed)

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 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.

Reference Type RESULT

PMID: 16885182 (View on PubMed)

Fransen 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.

Reference Type DERIVED

PMID: 19455501 (View on PubMed)

Other Identifiers

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153712

Identifier Type: -

Identifier Source: org_study_id