Ossification, HeterotopicPhase 4ArcoxiaNCT01022190
Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
A Phase 4 study testing Etoricoxib (Arcoxia) in people with Ossification, Heterotopic, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the study is to determine whether Arcoxia is effective in preventing heterotopic ossification after total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Ossification, Heterotopic
- What is being tested?
- Etoricoxib (Arcoxia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, 6500 HB
About this study
Official title: 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.
Read the 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.
- Conditions
- Ossification, Heterotopic
- Being tested
- Etoricoxib (Arcoxia)
- Keywords
- Arthroplasty, Hip, Cemented, Heterotopic ossification, Selective Cyclooxygenase-2 Inhibitors, Arthroplasty, Replacement, Hip Prosthesis, Cyclooxygenase Inhibitors
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoricoxib (Arcoxia)Drug
Also called Etoricoxib, Arcoxia
Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days
| Study group | Role | What they receive |
|---|---|---|
| Drug: Etoricoxib (Arcoxia, MSD), 90 mg. | Experimental | Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period. Receives: Drug: Etoricoxib (Arcoxia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Heterotopic Ossification (HO) at 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'.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ossification, HeterotopicStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaap Brunnekreef, Radboud University Medical Center
- Investigators
- R.P.H. Veth, Prof, MD, Study chair, Radboud University Nijmegen Medical Centre, department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022190
- Sponsor's protocol ID
- A2009-36182
- Acronym
- Arcoxia
- Status last verified
- Aug 2013
- First submitted
- 27 Nov 2009
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1080/17453670610013475.
PubMed 17453398van 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.
PubMed 17106714Brunnekreef 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.
PubMed 23359100
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Etoricoxib (Arcoxia) in Preventing Heterotopic Ossification After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01022190
- Acronym / sponsor ID
- Arcoxia / A2009-36182
- Conditions
- Ossification, Heterotopic
- Keywords
- Arthroplasty, Hip, Cemented, Heterotopic ossification, Selective Cyclooxygenase-2 Inhibitors, Arthroplasty, Replacement, Hip Prosthesis, Cyclooxygenase Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Posted 2 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: Etoricoxib (Arcoxia, MSD), 90 mg. | Experimental | Drug: Etoricoxib (Arcoxia)Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etoricoxib (Arcoxia)Also: Etoricoxib, ArcoxiaOral intake of 90 mg Etoricoxib (Arcoxia) during 7-days | Drug | Drug: Etoricoxib (Arcoxia, MSD), 90 mg. |
Primary outcome
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'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17453398van 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.
- Background: PubMed 17106714van 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.
- Results publication: PubMed 23359100Brunnekreef 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R.P.H. Veth, Prof, MD study chair
Radboud University Nijmegen Medical Centre, department of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoricoxib (Arcoxia) in people with Ossification, Heterotopic, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022190, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.