Condition: Hip Dislocation · Sponsor: JointResearch
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.
This description comes directly from the study's public registry record.
Amdanda Klaassen, Msc · +3120 599 3653 · A.D.Klaassen@olvg.nl
Okke Hoonhout · +3120 599 3653 · o.hoonhout@olvg.nl
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| OLVG Hospital | Amsterdam, North Holland, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06864897