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

August 31, 2013 updated by: Jaap Brunnekreef, Radboud University Medical Center

Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Etoricoxib, Arcoxia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

August 31, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2009-36182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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