NCT06864897 The 10-year Follow-up of the Delta-TT Trial.
| NCT ID | NCT06864897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JointResearch |
| Condition | Hip Dislocation |
| Study Type | OBSERVATIONAL |
| Enrollment | 51 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 51 participants in total. It began in 2024-10-10 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Rudolf Poolman, PhD
PRINCIPAL INVESTIGATOR
Orthopedic Surgeon
Frequently Asked Questions
Who can join the NCT06864897 clinical trial?
This trial is open to participants of all sexes, studying Hip Dislocation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06864897 currently recruiting?
Yes, NCT06864897 is actively recruiting participants. Contact the research team at A.D.Klaassen@olvg.nl for enrollment information.
Where is the NCT06864897 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06864897 clinical trial?
NCT06864897 is sponsored by JointResearch. The principal investigator is Rudolf Poolman, PhD at Orthopedic Surgeon. The trial plans to enroll 51 participants.