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

NCT00145730 | Completed Phase 4

• 1 other identifier: 153712
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Hip; Arthroplasty, Replacement, Hip; Arthritis, Rheumatoid

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Ibuprofen DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The George Institute: lead
• National Health and Medical Research Council, Australia: collaborator
• Medical Benefits Fund Australia Pty Ltd: collaborator

Related Publications (3)

• 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.

  PMID: 15020038 BACKGROUND

• 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.

  PMID: 16885182 RESULT

• 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.

  PMID: 19455501 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Ossification, Heterotopic

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Marlene H Fransen, PhD, MPH

  The George Institute, University of Sydney

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: February 1, 2002
• Study Completion: May 1, 2004
• Last Updated: November 29, 2006

Record last verified: 2005-09