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Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement (Arcoxia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022190
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : September 2, 2013
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):
Jaap Brunnekreef, Radboud University

Brief Summary:
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.

Condition or disease Intervention/treatment Phase
Ossification, Heterotopic Drug: Etoricoxib (Arcoxia) Phase 4

Detailed Description:

Rationale: Heterotopic ossification is a frequent complication after total hip replacement. Nonsteroidal anti-inflammatory drugs (NSAIDs) are known to effectively prevent heterotopic ossification, but gastrointestinal complaints are reported frequently. Selective cyclooxygenase-2 (COX-2) inhibiting NSAID produce less gastrointestinal side effects.

Objective: Preventing heterotopic ossification. Study design: A prospective two-stage study design for phase-2 clinical trials with 42 patients to determine if Arcoxia (a COX-2 inhibitor) 90-mg oral prevents heterotopic ossification. In the first stage, 19-patients are included. Another 23-patients are included when at least 90-percent of patients in first stage have Brooker classification 0, 1 or 2 at 6-months follow-up.

Study population: 42-patients with cemented total hip arthroplasty age 18 - 75 yr old.

Intervention: All subjects receive 90-mg Arcoxia oral for 7-days. Main study parameters/endpoints: The main study parameter is the degree of heterotopic ossification assessed on AP radiographs using the Brooker classification.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with participating into the research. Besides the oral intake of Arcoxia, no extra burden is associated with participating in the study. The postoperative care does not change. Radiographic examinations will be routinely performed the day before surgery, immediately after operation, at 6-weeks and 6-months after surgery. The degree of heterotopic ossification will be determined by x-ray assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty
Study Start Date : December 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: Drug: Etoricoxib (Arcoxia, MSD), 90 mg.
Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.
Drug: Etoricoxib (Arcoxia)
Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
Other Name: Etoricoxib, Arcoxia

Primary Outcome Measures :
  1. Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. [ Time Frame: 6 months postoperatively ]

    Percentage of participants in which Heterotopic Ossification of the hip was assessed, according to the Brooker grade.

    Brooker-0): No ossification. Brooker-1): Isolated bone islands, Brooker-2): Bone spurs from the pelvis or proximal femur;space between opposing surface ≥ 1 cm, Brooker-3): Bone spurs from the pelvis or proximal femur;space between opposing surface < 1 cm, Brooker-4): Apparent bony ankylosis. Brooker score 1 to 4 are considered 'heterotopic ossification'.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with primary or secondary hip osteoarthritis who are scheduled for cemented total hip replacement at the Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
  • Written informed consent is obtained from the patient or the legally accepted representative.

Exclusion Criteria:

  • Patients with rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures
  • Patients with previous allergic reaction on non-steroidal anti-inflammatory drugs
  • Patients with gastrointestinal complaints at admission, a history of gastrointestinal ulcers or perforations, inflammatory bowel-disease, hepatic dysfunction, renal dysfunction with a clearance below 30 ml/min and cardiac insufficiency.
  • Patients with blood pressure consistently > 140/90 mmHg and who have not been adequately controlled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022190

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Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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Study Chair: R.P.H. Veth, Prof, MD Radboud University Nijmegen Medical Centre, department of Orthopedics
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Jaap Brunnekreef, PhD, Radboud University Identifier: NCT01022190    
Other Study ID Numbers: A2009-36182
First Posted: December 1, 2009    Key Record Dates
Results First Posted: September 2, 2013
Last Update Posted: September 9, 2013
Last Verified: August 2013
Keywords provided by Jaap Brunnekreef, Radboud University:
Heterotopic ossification
Selective Cyclooxygenase-2 Inhibitors
Arthroplasty, Replacement
Hip Prosthesis
Cyclooxygenase Inhibitors
Additional relevant MeSH terms:
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Ossification, Heterotopic
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action