Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement (Arcoxia)

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ossification, Heterotopic	Drug: Etoricoxib (Arcoxia)	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty
Study Start Date :	December 2009
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Drug: Etoricoxib (Arcoxia, MSD), 90 mg.; Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.	Drug: Etoricoxib (Arcoxia); Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days; Other Name: Etoricoxib, Arcoxia

Outcome Measures

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Primary Outcome Measures :

1. 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'.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Netherlands
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB

Sponsors and Collaborators

Radboud University

Investigators

Study Chair:	R.P.H. Veth, Prof, MD	Radboud University Nijmegen Medical Centre, department of Orthopedics

More Information

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Additional Information:

Related Info 

Publications of Results:

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.

Other Publications:

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.

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. Epub 2006 Nov 16.

Responsible Party:	Jaap Brunnekreef, PhD, Radboud University
ClinicalTrials.gov Identifier:	NCT01022190 History of Changes
Other Study ID Numbers:	A2009-36182
First Posted:	December 1, 2009
Results First Posted:	September 2, 2013
Last Update Posted:	September 9, 2013
Last Verified:	August 2013

Keywords provided by Jaap Brunnekreef, Radboud University:

Arthroplasty; Hip; Cemented; Heterotopic ossification	Selective Cyclooxygenase-2 Inhibitors; Arthroplasty, Replacement; Hip Prosthesis; Cyclooxygenase Inhibitors

Additional relevant MeSH terms:

Ossification, Heterotopic; Pathologic Processes; Etoricoxib; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents