Migration and clinical outcomes of a novel cementless hydroxyapatite-coated titanium acetabular shell: two-year follow-up of a randomized controlled trial using radiostereometric analysis

医学 置信区间 随机对照试验 植入 荟萃分析 关节置换术 牙科 哈里斯髋关节评分 外科 材料科学 内科学 冶金
作者
Thies J.N. van der Lelij,Perla J. Marang‐van de Mheen,Bart L. Kaptein,Lennard A. Koster,Peter Ljung,Rob G. H. H. Nelissen,Søren Toksvig‐Larsen
出处
期刊:The bone & joint journal [British Editorial Society of Bone & Joint Surgery]
卷期号:106-B (2): 136-143 被引量:6
标识
DOI:10.1302/0301-620x.106b2.bjj-2023-0862.r1
摘要

Aims 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. Methods 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. Results 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). Conclusion 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. Cite this article: Bone Joint J 2024;106-B(2):136–143.
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