Trial Outcomes & Findings for Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement (NCT NCT01022190)

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

6 months postoperatively

Results posted on

2013-09-09

Participant Flow

All subjects have been recruited

No participants were excluded

Participant milestones

Participant milestones
Measure	Etoricoxib, 90 mg, Orally, Ones a Day 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.
Overall Study STARTED	42
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Heterotopic Ossification With Arcoxia After Total Hip Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etoricoxib n=42 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	54.2 years STANDARD_DEVIATION 15.8 • n=93 Participants
Sex: Female, Male Female	25 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Region of Enrollment Netherlands	42 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months postoperatively

Population: Patients who underwent total hip arthroplasty and received afterwards Etoricoxib medication.

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'.

Outcome measures

Outcome measures
Measure	Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period n=42 Participants Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants.
Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively.	38 percentage of participants

Adverse Events

Etoricoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study director

Radboud University Nijmegen Medical Centre

Phone: +31 24 36 13918

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place