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

Journal article (2024)

Authors

Thies J. N. van der Lelij Leiden University Medical Center
P.J. Marang-van de Mheen Safety and Security Science - TPM , Leiden University Medical Center
Bart L. Kaptein Leiden University Medical Center
Lennard A. Koster Leiden University Medical Center
Peter Ljung Hässleholm Hospital
Rob G.H.H. Nelissen Leiden University Medical Center
Sören Toksvig-Larsen Hässleholm Hospital, Lund University
Research Group
Safety and Security Science (TPM) (TU Delft)
Copyright: © 2024 Thies J. N. van der Lelij, P.J. Marang-van de Mheen, Bart L. Kaptein, Lennard A. Koster, Peter Ljung, Rob G. H. H. Nelissen, Sören Toksvig-Larsen
DOI: https://doi.org/10.1302/0301-620X.106B2.BJJ-2023-0862.R1
Titanium Migration Aseptic loosening Randomized controlled trial Acetabular cup Total hip arthroplasty Radiostereometric analysis Clinical outcome Acetabular shells Hydroxyapatite
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Published Date

2024

Language

English

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Faculty

Technology, Policy and Management

Department

Values Technology and Innovation

Research Group

Safety and Security Science

Abstract

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.