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Randomized Controlled Trial
. 2024 Feb 1;106-B(2):136-143.
doi: 10.1302/0301-620X.106B2.BJJ-2023-0862.R1.

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

Affiliations
Randomized Controlled Trial

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

Thies J N van der Lelij et al. Bone Joint J. .

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.

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Conflict of interest statement

B. L. Kaptein, P. Ljung, and T. J. N. van der Lelij report funding for this study from Stryker. T. J. N. van der Lelij also reports an oral presentation grant from Stryker to the LUMC to support travel to a scientific congress. B. L. Kaptein also reports a leadership or fiduciary role in the International Radiostereometry Society.

References

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