NCT01022190

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 2, 2013

Completed
Last Updated

September 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

November 27, 2009

Results QC Date

February 8, 2013

Last Update Submit

August 31, 2013

Conditions

Ossification, Heterotopic

Keywords

ArthroplastyHipCementedHeterotopic ossificationSelective Cyclooxygenase-2 InhibitorsArthroplasty, ReplacementHip ProsthesisCyclooxygenase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • 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'.

    6 months postoperatively

Study Arms (1)

Drug: Etoricoxib (Arcoxia, MSD), 90 mg.

EXPERIMENTAL

Intervention drug: Etoricoxib (Arcoxia, MSD), 90 mg, orally, one time a day, for a 7 day period.

Drug: Etoricoxib (Arcoxia)

Interventions

Etoricoxib (Arcoxia)DRUG

Oral intake of 90 mg Etoricoxib (Arcoxia) during 7-days

Also known as: Etoricoxib, Arcoxia
Drug: Etoricoxib (Arcoxia, MSD), 90 mg.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 17453398BACKGROUND

  • 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. doi: 10.1007/s00402-006-0243-1. Epub 2006 Nov 16.

    PMID: 17106714BACKGROUND

  • Brunnekreef 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.

    PMID: 23359100RESULT

Related Links

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Small sample size. However, due to ethical considerations, a two phase model is necessary to indicate effectivity of Etoricoxib in prevention HO in this phase.

Results Point of Contact

Title
Study director
Organization
Radboud University Nijmegen Medical Centre
+31 24 36 13918

Study Officials

  • R.P.H. Veth, Prof, MD

    Radboud University Nijmegen Medical Centre, department of Orthopedics

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 27, 2009

First Posted

December 1, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

September 9, 2013

Results First Posted

September 2, 2013

Record last verified: 2013-08

Locations

NL(1)