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

NCT06864897 · tracked via the Priya Life Science Netherlands tracker

Sponsor

JointResearch

Phase

Observational

Started

2024-10-10

Last updated

2025-03-14

Condition(s) studied

Hip Dislocation

Investigational drug(s) / intervention(s)

Total hip prothesisTotal hip prosthesis

Total hip prothesis: Total hip prothesis with a Delta-TT cup, H MAX S Stem and a ceramic liner

Total hip prosthesis: Total hip prosthesis with a Delta TT cup, H MAX S stem and polyethylene liner

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * Enrolled in the initial Delta-TT trial Exclusion Criteria: * 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.

Primary outcome measure(s)

Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner. — 10 Years
Measured in 3D translations and rotations by means of Radiostereometric X-ray images at 10-years postoperatively. Data will be summarized by treatment group. A mixed model analysis will be performed to assess cup migration, with liner type (polyethylene vs. ceramic) as the primary independent value. The primary outcome is the effect of the liner type on implant migration. Differences are considered significant for p-values below 0.05.

Trial sites (1)

Facility	City	Region	Status
OLVG Hospital	Amsterdam	North Holland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864897 on ClinicalTrials.gov ↗ ← All trials in the Netherlands