Question: In patients having total hip replacement, is celecoxib as
effective as ibuprofen in preventing heterotopic ossification 3 months after
surgery?
Design: Randomized (allocation concealed), blinded (outcome
assessors), controlled trial with 3-month follow-up.
Setting: A university hospital in Geneva, Switzerland.
Patients: 250 patients (mean age, 70 y; 54% women) with severe
osteoarthritis of the hip who were scheduled for total hip replacement.
Exclusion criteria were moderate to severe renal impairment, a history of
gastrointestinal ulcers, and immediate-type hypersensitivity to nonsteroidal
anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors. 240
patients (96%) were available for
follow-up.
Intervention: Patients were allocated to receive celecoxib, 200 mg
twice daily (n = 123), or ibuprofen, 400 mg 3 times daily (n = 127) for 10
days after surgery. All patients had total hip replacement by a direct lateral
approach, with an uncemented acetabular component and a cemented femoral stem,
and received prophylaxis for deep venous thrombosis with low-molecular-weight
heparin for 5 days after surgery and oral anticoagulation for the next 6
weeks.
Main outcome measures: Presence of heterotopic ossification on an
anteroposterior radiograph of the pelvis at 3 months. Heterotopic ossification
was assessed according to the Brooker classification (class I = islands of
bone within soft tissue around the hip; class II = bone spurs from the pelvis
or proximal aspect of the femur, leaving =1 cm between opposing bone
surfaces; class III = bone spurs from the pelvis or proximal aspect of the
femur, leaving <1 cm between opposing bone surfaces; and class IV =
apparent ankylosis of the hip). Adverse events (renal impairment, electrolyte
disorders, and gastrointestinal disturbances) were also assessed.
Main results: Analysis was by intention to treat. Celecoxib was more
effective than ibuprofen in preventing heterotopic ossification, and fewer
celecoxib recipients had Brooker classes II and III heterotopic ossification
(Table). Adjustment for age, sex, duration of surgery, and preoperative
anti-inflammatory treatment did not alter the results.
Conclusion: In patients having total hip replacement through a
direct lateral approach, celecoxib was more effective than ibuprofen in
preventing heterotopic ossification 3 months after surgery.
The study by Saudan and colleagues is a well-designed and executed
randomized controlled trial that clearly answers the question of whether
celecoxib is better than ibuprofen in preventing the radiographic appearance
of heterotopic ossification after total hip replacement.
Some aspects of this study that make it scientifically valid also lead to
difficulties in interpreting the data and applying it clinically. For example,
all of the procedures were performed through a direct lateral approach. Thus,
the results are not generalizable to other approaches. Furthermore, all of the
femoral components were cemented. Concern has previously been raised regarding
the effect that NSAIDs and COX-2 drugs may have on
osteointegration1.
This issue cannot be addressed in this study. This study is limited to the
radiographic appearance of heterotopic ossification and does not investigate
differences in clinical outcomes, such as pain and function, between the 2
groups.
Clinicians should be cautious in applying the findings of this study to a
larger clinical population. For example, the authors recommend that caution be
used with COX-2 drugs in "patients prone to cardiovascular
disorders." As a previous study has reported a surprisingly high number
of cardiovascular events after total hip
replacement2, this
message must be reemphasized. Side effects such as increased serum creatinine
levels were reported with both drugs; however, the study was not powered to
investigate differences in side-effect profiles between the 2 drugs.
If a surgeon is concerned about heterotopic ossification in a specific
patient receiving a total hip replacement through a direct lateral approach,
then this study clearly and validly shows that celecoxib is better than
ibuprofen in preventing radiographic heterotopic ossification. The findings do
not suggest that celecoxib should be used as a standard of care. Caution is
warranted if an uncemented stem is to be used.
Aspenberg P. Postoperative Cox
inhibitors and late prosthetic loosening—suspicion increases!
Acta Orthop. 2005;76:
733-4.76733
2005
[PubMed][CrossRef]
Gandhi R, Petruccelli D, Devereaux PJ,
Adili A, Hubmann M, de Beer J. Incidence and timing of myocardial infarction
after total joint arthroplasty. J Arthroplasty.
2006;21:
874-7.21874
2006
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