Clinical Trial: Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty
Brief Summary: The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.
Detailed Summary:
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.
Sponsor: Radboud University
Current Primary Outcome: 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'.
Original Primary Outcome: Degree of heterotopic ossification assessed on AP radiographs using the Brooker classification [ Time Frame: 0, 1 or 2 and 6-months follow-up. ]
Current Secondary Outcome:
Original Secondary Outcome: Gastrointestinal complaints [ Time Frame: Daily up to 7-days after operation. ]
Information By: Radboud University
Dates:
Date Received: November 27, 2009
Date Started: December 2009
Date Completion:
Last Updated: August 31, 2013
Last Verified: August 2013
