Orthopaedics Department, Hospital Universitario La Paz-Idi Paz, Madrid, Spain.
Bioengineering, Biomaterials and Nanomedicine, Biomedical Research Networking Center, Madrid, Spain.
Bone Joint J. 2022 Sep;104-B(9):1032-1038. doi: 10.1302/0301-620X.104B9.BJJ-2022-0434.R1.
A significant reduction in wear at five and ten years was previously reported when comparing Durasul highly cross-linked polyethylene with nitrogen-sterilized Sulene polyethylene in total hip arthroplasty (THA). We investigated whether the improvement observed at the earlier follow-up continued, resulting in decreased osteolysis and revision surgery rates over the second decade.
Between January 1999 and December 2001, 90 patients underwent surgery using the same acetabular and femoral components with a 28 mm metallic femoral head and either a Durasul or Sulene liner. A total of 66 hips of this prospective randomized study were available for a minimum follow-up of 20 years. The linear femoral head penetration rate was measured at six weeks, one year, and annually thereafter, using the Dorr method on digitized radiographs with a software package.
In the Durasul group, no patients underwent revision due to loosening or showed radiological evidence of osteolysis. In the Sulene group, four patients (four hips) were revised due to femoral component loosening. The 20-year cumulative failure incidence in the presence of the competing event of death for revision surgery was 4.5% (95% confidence interval (CI) 0.8 to 13.6) in the Durasul group, and 8.9% (95% CI 2.8 to 19.5) in the Sulene group. The mean wear one year after surgery was 0.09 mm (SD 0.007) in the Durasul group and 0.24 (SD 0.015) in the Sulene group (p < 0.001). From one to 20 years after surgery, the mean total penetration was 0.32 mm (SD 0.045) in the Durasul group and 1.07 mm (SD 0.13) in the Sulene group (p < 0.001). Mean femoral head penetration at 20 years was approximately 70.0% less in the Durasul group than the Sulene group.
The significant reduction in femoral head penetration obtained with the Durasul compared with Sulene in uncemented THA resulted in lower osteolysis and revision rates after 20 years.Cite this article: 2022;104-B(9):1032-1038.
先前的研究表明，在全髋关节置换术（THA）中，与经过氮离子辐射灭菌的 Sulene 聚乙烯相比，Durasul 超高交联聚乙烯可显著降低 5 年和 10 年时的磨损。我们研究了在早期随访中观察到的改善是否持续存在，从而在第二个十年中降低了骨溶解和翻修手术的发生率。
1999 年 1 月至 2001 年 12 月，90 例患者接受了相同髋臼和股骨组件的手术，采用 28mm 金属股骨头和 Durasul 或 Sulene 衬垫。这项前瞻性随机研究中共有 66 例髋关节可获得至少 20 年的随访。使用数字化射线照片和软件包，根据 Dorr 方法，在 6 周、1 年和此后每年测量线性股骨头穿透率。
在 Durasul 组中，没有患者因松动而需要翻修，也没有影像学证据表明存在骨溶解。在 Sulene 组中，4 例（4 髋）因股骨部件松动而需要翻修。在存在死亡这一竞争事件的情况下，20 年时，Durasul 组翻修手术的累积失败发生率为 4.5%（95%置信区间（CI）0.8 至 13.6），Sulene 组为 8.9%（95%CI 2.8 至 19.5）。Durasul 组术后 1 年的平均磨损量为 0.09mm（SD 0.007），Sulene 组为 0.24mm（SD 0.015）（p<0.001）。从术后 1 年到 20 年，Durasul 组的总穿透平均为 0.32mm（SD 0.045），Sulene 组为 1.07mm（SD 0.13）（p<0.001）。Durasul 组在 20 年时的股骨头穿透平均减少约 70.0%，明显低于 Sulene 组。
与非骨水泥 THA 中使用的 Sulene 相比，Durasul 可显著降低股骨头穿透率，这导致 20 年后骨溶解和翻修率降低。
