The 10-year Follow-up of the Delta-TT Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total hip prothesis, Total hip prosthesis.
- Who it may be relevant to
- Registry conditions: Hip Dislocation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
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
Primary outcome measures
- Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner. [Time frame: 10 Years]
Secondary outcome measures (4)
- Long-term (10-year) migration pattern of the H-MAX S Stem compared between a ceramic and polyethylene liner. [Time frame: 10 years]
- Implant survival of the Delta TT cup and H-MAX S stem. [Time frame: 10 years]
- Radiographic signs of osteolysis around the Delta-TT cup. [Time frame: 10 years]
- Radiographic signs of osteolysis around the H-Max S stem. [Time frame: 10 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Netherlands · 1 center
- OLVG Hospital — Amsterdam
Identifiers
NCT: NCT06864897 · NL86542.100.24