Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Recruitment status was Recruiting
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.
Drug: Etoricoxib (Arcoxia)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty|
- Degree of heterotopic ossification assessed on AP radiographs using the Brooker classification [ Time Frame: 0, 1 or 2 and 6-months follow-up. ] [ Designated as safety issue: No ]
- Gastrointestinal complaints [ Time Frame: Daily up to 7-days after operation. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Experimental: Drug: Etoricoxib (Arcoxia, MSD), 90 mg.||
Drug: Etoricoxib (Arcoxia)
Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
Other Name: Etoricoxib, Arcoxia
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.
|Contact: B.W. Schreurs, MD, PhD||+31 24 36 13918||B.Schreurs@orthop.umcn.nl|
|Contact: J.J. Brunnekreef, MSc||+31 24 36 10810||J.Brunnekreef@orthop.umcn.nl|
|Radboud University Nijmegen Medical Center||Recruiting|
|Nijmegen, Netherlands, 6500 HB|
|Contact: B.W. Schreurs, MD, PhD +31 24 36 13918 B.Schreurs@orthop.umcn.nl|
|Sub-Investigator: P. Hoogervorst, MD|
|Sub-Investigator: Akkie Rood, MD|
|Study Chair:||R.P.H. Veth, Prof, MD||Radboud University Nijmegen Medical Centre, department of Orthopedics|