This record was last updated March 14, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This 10-year follow-up study aims to further investigate long-term migration patterns of the uncemented Delta-TT cup and H-MAX S stem, comparing outcomes between ceramic and polyethylene liners. Given the predictive value of early RSA migration patterns at the 2-year mark for identifying implants at risk of aseptic loosening, we hypothesize that the Delta-TT cup will demonstrate good stability at the 10-year postoperative mark. Besides, it is hypothesized that migration of Delta TT-cups is comparable between ceramic and polyethylene liners.
The primary objective of this study is to measure the long-term stability of the Delta TT cup, combined with either a ceramic or cross-linked polyethylene liner, by means of RSA at 10-years postoperatively.
Secondary objectives are to measure long-term stability of the H-MAX S stem, by means of RSA at 10-year postoperatively. Furthermore the study aims to measure implant survival rates and patient-reported outcomes for both the Delta-TT cup and H-MAX S stem, comparing outcomes between the ceramic and polyethylene group.
Protocol Amendment History
1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-03.