The 10-year Follow-up of the Delta-TT Trial.

Recruiting now

Conditions studied: Hip Dislocation

In brief

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.

Key facts

Study ID

NCT06864897

Run by

JointResearch

People needed

51

Starts

2024-10-10

Expected to finish

2029-05-01

Last updated by the study team

2025-03-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in the initial Delta-TT trial

You may not qualify if…

• Patient is unable or unwilling to sign the Informed Consent specific to this study.
• Patient is unsuitable for participation in the study based on the investigator's judgement.

Where it is running

• OLVG Hospital — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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