Deptartment of Orthopaedics and Traumatology, Ospedale G. Bernabeo, Ortona, Italy.
J Orthop Traumatol. 2012 Jun;13(2):63-7. doi: 10.1007/s10195-012-0180-4. Epub 2012 Feb 23.
In spite of the proven efficacy of pharmacological prophylaxis of heterotopic ossification following total hip arthroplasty, its routine use is still debated, and no data are available regarding the adherence to its administration in clinical practice.
In this prospective, observational, multicenter study, 480 consecutive patients operated on for primary total hip arthroplasty during the year 2009 were followed radiographically for 12 months after surgery in order to assess the incidence of periprosthetic heterotopic ossification. Surgeons were free to choose whether to administer pharmacological prophylaxis, and were asked to keep a record of the duration of the prophylaxis (if used) or the reasons for not using it. To facilitate the statistical analysis, all of the participating centers agreed to use only one drug (celecoxib) that had already proven to be effective.
368 patients were administered celecoxib and 112 patients did not receive any prophylaxis. Reported reasons for not administering celecoxib prophylaxis were the surgeon's opinion that prophylaxis was not needed on a routine basis (84/112 patients, 75%), previous history of gastrointestinal bleeding (17.8%), and concomitant cardiorenal pathologies (7.1%). The overall incidence of heterotopic ossification in the celecoxib-treated patients was 23% (no cases of Brooker grade 3 or 4 ossifications), compared to 55% in the untreated patients (Brooker grade 3 and 4: 8.9%). Multivariate analysis showed that celecoxib prophylaxis was the single most important variable when predicting the occurrence of heterotopic ossification.
This study confirms the efficacy and tolerability of celecoxib for the prophylaxis of heterotopic ossification after total hip arthroplasty, and shows how the surgeon's belief that routine prevention is not required still plays an important role in the determination of this complication, together with the fear of possible unwanted side effects.
尽管药物预防全髋关节置换术后异位骨化已被证实有效,但仍存在争议,目前尚无关于其在临床实践中应用的依从性的数据。
在这项前瞻性、观察性、多中心研究中,对 2009 年行初次全髋关节置换术的 480 例连续患者进行了术后 12 个月的放射学随访,以评估假体周围异位骨化的发生率。外科医生可以自由选择是否使用药物预防,并且需要记录预防的持续时间(如果使用)或不使用的原因。为了便于统计分析,所有参与中心均同意仅使用一种已被证实有效的药物(塞来昔布)。
368 例患者使用了塞来昔布,112 例患者未接受任何预防。未使用塞来昔布预防的报告原因包括外科医生认为常规预防不必要(84/112 例,75%)、既往胃肠道出血史(17.8%)和并存的心脏-肾脏疾病(7.1%)。接受塞来昔布预防的患者中异位骨化的总体发生率为 23%(无 Brooker 3 或 4 级骨化),而未接受预防的患者中为 55%(Brooker 3 和 4 级:8.9%)。多变量分析表明,塞来昔布预防是预测异位骨化发生的最重要单一变量。
本研究证实了塞来昔布预防全髋关节置换术后异位骨化的疗效和耐受性,并且表明外科医生认为常规预防不必要的信念,以及对可能出现的不良副作用的担忧,仍然在决定这种并发症方面发挥着重要作用。