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

NCT06864897 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2025-03-14

No results posted yet for this 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.

Conditions

  • Hip Dislocation

Interventions

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

Sponsors & Collaborators

  • JointResearch

    lead OTHER

Principal Investigators

  • Rudolf Poolman, PhD · Orthopedic Surgeon

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-05-01
Completion
2029-05-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864897 on ClinicalTrials.gov