Actively Recruiting
The 10-year Follow-up of the Delta-TT Trial.
Led by JointResearch · Updated on 2025-03-14
51
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The 10-year Follow-up of the Delta-TT Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in the initial Delta-TT trial
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
OLVG Hospital
Amsterdam, North Holland, Netherlands, 1091 AC
Actively Recruiting
Research Team
A
Amdanda Klaassen, Msc
CONTACT
O
Okke Hoonhout
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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