Comparative clinical study of the prophylaxis of heterotopic ossifications after total hip arthroplasty using etoricoxib or diclofenac.

PURPOSE: This study investigated whether etoricoxib (COX-II blocker) has a superior efficacy of preventing heterotopic ossification (HO) after total hip arthroplasty (THA) compared to diclofenac (non-selective NSAID). METHODS: One hundred patients were included (50 in each group) in this single centre, prospective, double-blinded, randomized, controlled trial. Etoricoxib (90 mg) was administered once and diclofenac (75 mg) twice per day for a perioperative period of nine days. The incidence of HO was evaluated on radiographs of the pelvis six months after surgery. RESULTS: Eighty nine of 100 (89 %) patients could be analysed. The overall HO incidence was 37.8 %. There was no significant difference between both study groups. Twelve patients (27.3 %) of the DIC group and 13 patients (28.9 %) of the ETO group showed Brooker grade I ossifications. Five patients (11.4 %) of the DIC and four patients of the ETO (8.9 %) group showed grade II HO formations. No class III or IV HO formations occured in both groups. Ad hoc analysis detected a negative correlation between HO incidence and limited abduction and internal rotation of the hip. CONCLUSIONS: Etoricoxib and diclofenac are equally effective for oral HO prophylaxis after primary cementless THA when given for nine peri-operative days to ensure a full recovery and high patient satisfaction.

Perioperative blood loss and gastrointestinal tolerability of etoricoxib and diclofenac in total hip arthroplasty (ETO-DIC study): a single-center, prospective double-blinded randomized controlled trial.

OBJECTIVE: Non-selective NSAIDs can cause serious gastrointestinal side-effects. Selective COX-2 blockers are a reasonable alternative for pain treatment. They do not seem to affect platelet function and consequently cause a lower perioperative blood loss than non-selective NSAIDs. This study compared etoricoxib and diclofenac during a perioperative (9 days) period after THA to investigate total blood loss and gastrointestinal tolerability. The hypothesis was that etoricoxib is superior to diclofenac. METHODS: A total of 100 patients (50 in each group) were included in this trial. Etoricoxib (90 mg) was administered once and diclofenac sodium (75 mg) twice daily for 9 days. Total blood loss during and after primary cementless THA was detected. The rate of adverse events (AEs) and serious adverse events (SAEs) was analyzed to detect gastrointestinal tolerability. RESULTS: The mean total blood loss (calculated) was 1548 ± SD 468 ml in the etoricoxib (ETO) group and 1649 (SD 547) ml in the diclofenac (DIC) group. The mean duration of THA was 81 min (SD 29) in the DIC and 75 min (SD 30) in the ETO group. Hence, the mean calculated total blood loss was 101 ml higher in the DIC group. This difference was not statistically significant (p = 0.334). Fifty-six patients (28 in each group) received a cell saver retransfusion, but only one patient (ETO group) needed an additional red blood cell transfusion. The hidden blood loss was 1067 ml (SD 603) in the DIC group and 999 ml (SD 378) in the ETO group. The gastrointestinal tolerability (number of adverse and serious adverse events) was not significantly different between groups. CONCLUSION: There was no statistically significant difference in perioperative blood loss after primary THA under etoricoxib (90 mg) compared to diclofenac (75 mg). Furthermore, no gastrointestinal superiority of etoricoxib could be detected during a short period of 9 days.