Clinical trial NCT01022190: Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Official title: Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ossification, Heterotopic
Keywords: Arthroplasty
Hip
Cemented
Heterotopic ossification
Selective Cyclooxygenase-2 Inhibitors
Arthroplasty, Replacement
Hip Prosthesis
Cyclooxygenase Inhibitors
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

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.

Primary outcomes:
measure: Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively.
timeFrame: 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, department of Orthopedics
name: R.P.H. Veth, Prof, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.