Phase 4
N=42
Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Ossification, Heterotopic
Bottom Line
View on ClinicalTrials.gov: NCT01022190 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. — 38 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Etoricoxib (Arcoxia) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radboud University Medical Center
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. |
38 | — |
Summary
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01022190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.