Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands.
Safety & Security Science and Centre for Safety in Healthcare, Delft University of Technology, Delft, Netherlands.
Bone Joint J. 2024 Feb 1;106-B(2):136-143. doi: 10.1302/0301-620X.106B2.BJJ-2023-0862.R1.
The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface.
Overall, 87 patients undergoing total hip arthroplasty (THA) were randomized to either a Trident II HA or Trident HA shell, each cementless with clusterholes and HA-coating. All components were used in combination with a cemented Exeter V40 femoral stem. Implant migration was measured using radiostereometric analysis (RSA), with radiographs taken within two days of surgery (baseline), and at three, 12, and 24 months postoperatively. Proximal acetabular component migration was the primary outcome measure. Clinical scores and patient-reported outcome measures (PROMs) were collected at each follow-up.
Mean proximal migrations at three, 12, and 24 months were 0.08 mm (95% confidence interval (CI) 0.03 to 0.14), 0.11 mm (95% CI 0.06 to 0.16), and 0.14 mm (95% CI 0.09 to 0.20), respectively, in the Trident II HA group, versus 0.11 mm (95% CI 0.06 to 0.16), 0.12 mm (95% CI 0.07 to 0.17), and 0.14 mm (95% CI 0.09 to 0.19) in the Trident HA group (p = 0.875). No significant differences in translations or rotations between the two designs were found in any other direction. Clinical scores and PROMs were comparable between groups, except for an initially greater postoperative improvement in Hip disability and Osteoarthritis Outcome Symptoms score in the Trident HA group (p = 0.033).
The Trident II clusterhole HA shell has comparable migration with its predecessor, the Trident hemispherical HA cluster shell, suggesting a similar risk of long-term aseptic loosening.
本研究旨在比较新型非骨水泥羟基磷灰石(HA)涂层钛髋臼壳与具有相同几何设计但采用不同钛表面处理工艺的前一代产品的两年迁移和临床结果。
共有 87 例接受全髋关节置换术(THA)的患者被随机分为 Trident II HA 或 Trident HA 髋臼壳组,两组均采用非骨水泥、集群孔和 HA 涂层。所有组件均与经皮固定 Exeter V40 股骨柄一起使用。使用放射立体测量分析(RSA)测量植入物迁移,术后两天内(基线)以及术后 3、12 和 24 个月拍摄 X 线片。髋臼近端组件迁移是主要的观察指标。每次随访时收集临床评分和患者报告的结果测量(PROM)。
在 Trident II HA 组中,术后 3、12 和 24 个月的髋臼近端平均迁移量分别为 0.08 毫米(95%置信区间(CI)0.03 至 0.14)、0.11 毫米(95% CI 0.06 至 0.16)和 0.14 毫米(95% CI 0.09 至 0.20),在 Trident HA 组中分别为 0.11 毫米(95% CI 0.06 至 0.16)、0.12 毫米(95% CI 0.07 至 0.17)和 0.14 毫米(95% CI 0.09 至 0.19)(p = 0.875)。在任何其他方向上,两个设计之间没有发现明显的平移或旋转差异。两组的临床评分和 PROM 相似,除了 Trident HA 组的术后髋关节残疾和骨关节炎结果症状评分最初有更大的改善(p = 0.033)。
Trident II 集群孔 HA 壳与前一代产品 Trident 半球形 HA 集群壳具有相似的迁移性,表明长期无菌松动的风险相似。