Long-term follow-up on hip implant stability after 10 years
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.
This study looks at how well hip implants have held up over 10 years for patients who had them, comparing different materials to see which is more stable and less likely to loosen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Sex | All |
| Sponsor | JointResearch Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06864897 on ClinicalTrials.gov |
What this trial studies
This observational study follows up on patients from the initial Delta-TT trial to assess the long-term migration patterns of the Delta-TT cup and H-MAX S stem. It compares the outcomes of ceramic and polyethylene liners in terms of stability and potential risk of aseptic loosening. The study utilizes radiostereometric analysis (RSA) to measure implant stability at the 10-year postoperative mark, aiming to provide insights into implant performance over time. Additionally, it evaluates patient-reported outcomes and implant survival rates.
Who should consider this trial
Good fit: Ideal candidates are individuals who were enrolled in the initial Delta-TT trial and have undergone total hip prosthesis surgery.
Not a fit: Patients who are unable or unwilling to provide informed consent or are deemed unsuitable by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the long-term effectiveness and safety of hip implants, guiding future surgical decisions.
How similar studies have performed: Other studies have shown success in using RSA to evaluate implant stability, making this approach both validated and relevant.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amsterdam, North Holland
- OLVG Hospital — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Rudolf Poolman, PhD — Orthopedic Surgeon
- Study coordinator: Amdanda Klaassen, Msc
- Email: A.D.Klaassen@olvg.nl
- Phone: +3120 599 3653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.