The 10-year Follow-up of the Delta-TT Trial.
ConditionHip Dislocation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorJointResearch
About this trial
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
Qualifiers
Enrolled in the initial Delta-TT trial
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Total hip prothesis
- Total hip prosthesis
Treatment groups
51 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov