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

JointResearch

Status

Enrolling

Conditions

Hip Dislocation

Treatments

Device: Total hip prothesis

Device: Total hip prosthesis

Study type

Observational

Funder types

Other

Identifiers

NCT06864897

NL86542.100.24

Details and patient eligibility

About

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.

Enrollment

51 estimated patients

Sex

All

Volunteers

No 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.