NCT06864897

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

The 10-year Follow-up of the Delta-TT Trial: Stability of the Delta-TT Cup with Polyethylene Insert Compared to the Delta-TT Cup with Ceramic Insert.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 51 (estimated)
• Sponsor: JointResearch · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Dislocation

Interventions

Type	Name	Description
DEVICE	Total hip prothesis	Total hip prothesis with a Delta-TT cup, H MAX S Stem and a ceramic liner
DEVICE	Total hip prosthesis	Total hip prosthesis with a Delta TT cup, H MAX S stem and polyethylene liner

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-05-01
• Completion: 2029-05-01
• First posted: 2025-03-07
• Last updated: 2025-03-14

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study