Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaap Brunnekreef, Radboud University
ClinicalTrials.gov Identifier:
NCT01022190
First received: November 27, 2009
Last updated: August 31, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Ossification, Heterotopic
Drug: Etoricoxib (Arcoxia)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]

    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'.



Enrollment: 42
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022190

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

Additional Information:
Publications:
Responsible Party: Jaap Brunnekreef, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01022190     History of Changes
Other Study ID Numbers: A2009-36182
Study First Received: November 27, 2009
Results First Received: February 8, 2013
Last Updated: August 31, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by 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
Cyclooxygenase Inhibitors
Etoricoxib
Cyclooxygenase 2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014