Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Recruitment status was Recruiting
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Purpose
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteochondritis 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 |
- Degree of heterotopic ossification assessed on AP radiographs using the Brooker classification [ Time Frame: 0, 1 or 2 and 6-months follow-up. ] [ Designated as safety issue: No ]
- Gastrointestinal complaints [ Time Frame: Daily up to 7-days after operation. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 42 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Drug: Etoricoxib (Arcoxia, MSD), 90 mg. |
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 |
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| Contact: B.W. Schreurs, MD, PhD | +31 24 36 13918 | B.Schreurs@orthop.umcn.nl |
| Contact: J.J. Brunnekreef, MSc | +31 24 36 10810 | J.Brunnekreef@orthop.umcn.nl |
| Netherlands | |
| Radboud University Nijmegen Medical Center | Recruiting |
| Nijmegen, Netherlands, 6500 HB | |
| Contact: B.W. Schreurs, MD, PhD +31 24 36 13918 B.Schreurs@orthop.umcn.nl | |
| Sub-Investigator: P. Hoogervorst, MD | |
| Sub-Investigator: Akkie Rood, MD | |
| Study Chair: | R.P.H. Veth, Prof, MD | Radboud University Nijmegen Medical Centre, department of Orthopedics |
More Information
Publications:
| Responsible Party: | B.W. Schreurs, MD, PhD, Radboud University |
| ClinicalTrials.gov Identifier: | NCT01022190 History of Changes |
| Other Study ID Numbers: | A2009-36182 |
| Study First Received: | November 27, 2009 |
| Last Updated: | October 19, 2010 |
| 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 Osteochondritis Pathologic Processes Bone Diseases Musculoskeletal Diseases Cartilage Diseases Connective Tissue Diseases 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 May 22, 2013