Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
NCT ID: NCT01022190
Last Updated: 2013-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2009-12-31
2011-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Drug: Etoricoxib (Arcoxia, MSD), 90 mg.
Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.
Etoricoxib (Arcoxia)
Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
Interventions
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Etoricoxib (Arcoxia)
Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent is obtained from the patient or the legally accepted representative.
Exclusion Criteria
* 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.
18 Years
95 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Jaap Brunnekreef
PhD
Principal Investigators
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R.P.H. Veth, Prof, MD
Role: STUDY_CHAIR
Radboud University Nijmegen Medical Centre, department of Orthopedics
Locations
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Radboud University Nijmegen Medical Center
Nijmegen, , Netherlands
Countries
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References
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van der Heide HJ, Rijnberg WJ, Van Sorge A, Van Kampen A, Schreurs BW. Similar effects of rofecoxib and indomethacin on the incidence of heterotopic ossification after hip arthroplasty. Acta Orthop. 2007 Feb;78(1):90-4. doi: 10.1080/17453670610013475.
van der Heide HJ, Koorevaar RC, Lemmens JA, van Kampen A, Schreurs BW. Rofecoxib inhibits heterotopic ossification after total hip arthroplasty. Arch Orthop Trauma Surg. 2007 Sep;127(7):557-61. doi: 10.1007/s00402-006-0243-1. Epub 2006 Nov 16.
Brunnekreef JJ, Hoogervorst P, Ploegmakers MJ, Rijnen WH, Schreurs BW. Is etoricoxib effective in preventing heterotopic ossification after primary total hip arthroplasty? Int Orthop. 2013 Apr;37(4):583-7. doi: 10.1007/s00264-013-1781-0. Epub 2013 Jan 29.
Related Links
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Related Info
Other Identifiers
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A2009-36182
Identifier Type: -
Identifier Source: org_study_id