Schilcher J, Palm L, Ivarsson I, Aspenberg P
Linköping University, Linköping, Sweden.
Bone Joint J. 2017 Mar;99-B(3):317-324. doi: 10.1302/0301-620X.99B3.BJJ-2016-0531.R1.
Post-operative migration of cemented acetabular components as measured by radiostereometric analysis (RSA) has a strong predictive power for late, aseptic loosening. Also, radiolucent lines predict late loosening. Migration has been reduced by systemic bisphosphonate treatment in randomised trials of hip and knee arthroplasty. Used as a local treatment, a higher local dose of bisphosphonate can be achieved without systemic exposure. We wished to see if this principle could be applied usefully in total hip arthroplasty (THA).
In this randomised placebo-controlled, double-blinded trial with 60 participants, we compressed gauze soaked in bisphosphonate solution (ibandronate) or saline against the acetabular bone bed immediately before cementing the acetabular component. RSA, classification of radiolucent lines, the Harris Hip Score (HHS) and the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) were carried out at three-, six-, 12-, and 24-month follow-up.
Migration of the cemented acetabular component relative to the pelvis was reduced by movement almost half in the ibandronate group, when measured as maximum total point or as movement of the femoral head (p = 0.001 and 0.004, respectively). Radiolucent lines after one year were classified as absent, partial or complete, and correlated with treatment (rho 0.37; p = 0.004). Only three of 30 patients in the ibandronate group had complete lines, compared with 13 of 28 in the placebo group (p = 0.002). There were no significant effects on HHS or WOMAC score.
Considering the power of RSA to predict loosening of cemented acetabular components, and the likelihood that radiolucent lines indicate risk of loosening, these data suggest that local treatment with a bisphosphonate can reduce the risk of late aseptic loosening. Cite this article: 2017;99-B:317-24.
通过放射立体测量分析(RSA)测定的骨水泥型髋臼假体术后移位对晚期无菌性松动具有很强的预测能力。此外,透光线也可预测晚期松动。在髋关节和膝关节置换术的随机试验中,全身使用双膦酸盐治疗可减少移位。作为局部治疗,可在不产生全身暴露的情况下实现更高的局部双膦酸盐剂量。我们希望了解这一原理是否能有效地应用于全髋关节置换术(THA)。
在这项有60名参与者的随机、安慰剂对照、双盲试验中,我们在骨水泥固定髋臼假体之前,将浸泡在双膦酸盐溶液(伊班膦酸盐)或盐水中的纱布紧压在髋臼骨床上。在术后3个月、6个月、12个月和24个月进行RSA、透光线分类、Harris髋关节评分(HHS)以及西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评估。
以最大总分或股骨头移位来衡量,伊班膦酸盐组骨水泥型髋臼假体相对于骨盆的移位减少了近一半(分别为p = 0.001和0.004)。术后一年的透光线分为无、部分或完全,且与治疗相关(rho 0.37;p = 0.004)。伊班膦酸盐组30名患者中只有3例出现完全透光线,而安慰剂组28名患者中有13例(p = 0.002)。对HHS或WOMAC评分无显著影响。
考虑到RSA预测骨水泥型髋臼假体松动的能力,以及透光线表明松动风险的可能性,这些数据表明双膦酸盐局部治疗可降低晚期无菌性松动的风险。引用本文:2017;99 - B:317 - 24。