Division of Orthopaedics, Department of Clinical Sciences at Danderyd Hospital, Karolinska Institute, Danderyds Sjukhus, 18288 Stockholm, Sweden.
J Bone Joint Surg Am. 2011 Oct 19;93(20):1857-64. doi: 10.2106/JBJS.J.01646.
Bone loss leading to late-occurring periprosthetic femoral fracture is a mode of failure in cementless total hip arthroplasty. The aim of this trial was to investigate the effect of a bisphosphonate, risedronate, on femoral periprosthetic bone resorption following total hip arthroplasty in patients with osteoarthritis of the hip.
We enrolled seventy-three patients between the ages of forty and seventy years who were scheduled to undergo total hip arthroplasty in a single-center, randomized, double-blind, placebo-controlled trial. Subjects were randomly assigned to receive either 35 mg of risedronate (n = 36) or a placebo (n = 37) orally once weekly for six months. The primary end point was the change in bone mineral density in Gruen femoral zones 1 and 7. Bone mineral density scans were made preoperatively and at two days and three, six, twelve, and twenty-four months postoperatively. Secondary end points included migration of the femoral stem and clinical outcome.
Seventy of the seventy-three patients (thirty-three in the risedronate group and thirty-seven in the placebo group) were analyzed for the primary end point. The mean bone mineral density in zone 1 was 9.2% higher (95% confidence interval [CI], 4.2% to 14.1%) in the risedronate group than in the placebo group at six months postoperatively and 7.2% higher (95% CI, 1.0% to 13.3%) at one year. The mean bone mineral density in zone 7 was 8.0% higher (95% CI, 2.7% to 13.4%) in the risedronate group than in the placebo group at six months postoperatively and 4.3% higher (95% CI, -1.5% to 10.1%) at one year. Migration of the femoral stem, the clinical outcome, and the frequency of adverse events did not differ between the groups.
Risedronate taken once weekly for six months following total hip arthroplasty was effective in reducing periprosthetic bone resorption around an uncemented femoral stem up to one year after surgery but had no discernible effect on implant migration or clinical outcome. Future studies of bisphosphonate treatment following total hip arthroplasty should focus on clinically relevant end points such as the risks of fracture and revision arthroplasty.
导致晚期发生假体周围股骨骨折的骨丢失是无水泥全髋关节置换术失效的一种模式。本试验旨在研究双膦酸盐雷奈酸锶对髋关节骨关节炎患者全髋关节置换术后股骨假体周围骨吸收的影响。
我们纳入了 73 名年龄在 40 至 70 岁之间的患者，这些患者计划在单中心、随机、双盲、安慰剂对照试验中接受全髋关节置换术。受试者被随机分配接受每周一次 35 毫克雷奈酸锶（n = 36）或安慰剂（n = 37）口服治疗 6 个月。主要终点是Gruen 股骨区 1 和 7 的骨密度变化。在术前以及术后 2 天、3 天、6 天、12 天和 24 天进行骨密度扫描。次要终点包括股骨柄的迁移和临床结果。
73 名患者中的 70 名（雷奈酸锶组 33 名，安慰剂组 37 名）被分析主要终点。雷奈酸锶组术后 6 个月时，1 区骨密度平均增加 9.2%（95%置信区间，4.2%至 14.1%），术后 1 年时增加 7.2%（95%置信区间，1.0%至 13.3%）。雷奈酸锶组术后 6 个月时，7 区骨密度平均增加 8.0%（95%置信区间，2.7%至 13.4%），术后 1 年时增加 4.3%（95%置信区间，-1.5%至 10.1%）。股骨柄的迁移、临床结果和不良事件的频率在两组之间没有差异。
全髋关节置换术后每周一次服用雷奈酸锶 6 个月可有效减少非水泥股骨柄周围假体周围骨吸收，术后 1 年仍有效，但对植入物迁移或临床结果无明显影响。全髋关节置换术后双膦酸盐治疗的未来研究应侧重于临床相关终点，如骨折和翻修关节置换术的风险。
