Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement
Study Details
Study Description
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 |
|---|---|---|
|
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
Arms and Interventions
| 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:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. [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
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboud University Nijmegen Medical Center | Nijmegen | Netherlands | 6500 HB |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Study Chair: R.P.H. Veth, Prof, MD, Radboud University Nijmegen Medical Centre, department of Orthopedics
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- A2009-36182
Study Results
Participant Flow
| Recruitment Details | All subjects have been recruited |
|---|---|
| Pre-assignment Detail | No participants were excluded |
| Arm/Group Title | Etoricoxib, 90 mg, Orally, Ones a Day |
|---|---|
| Arm/Group Description | Patients who underwent total hip arthroplasty were administered Etoricoxib, 90 mg, orally, one a day for a 7 day period to prevent heterotopic ossification of the hip joint after the operation. |
| Period Title: Overall Study | |
| STARTED | 42 |
| COMPLETED | 42 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Etoricoxib |
|---|---|
| Arm/Group Description | |
| Overall Participants | 42 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
42
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.2
(15.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
25
59.5%
|
| Male |
17
40.5%
|
| Region of Enrollment (participants) [Number] | |
| Netherlands |
42
100%
|
Outcome Measures
| Title | Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively. |
|---|---|
| Description | 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'. |
| Time Frame | 6 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who underwent total hip arthroplasty and received afterwards Etoricoxib medication. |
| Arm/Group Title | Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period |
|---|---|
| Arm/Group Description | Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants. |
| Measure Participants | 42 |
| Number [percentage of participants] |
38
90.5%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Etoricoxib | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Etoricoxib | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Etoricoxib | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Etoricoxib | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Study director |
|---|---|
| Organization | Radboud University Nijmegen Medical Centre |
| Phone | +31 24 36 13918 |
- A2009-36182