The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study. The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.
Study Type
OBSERVATIONAL
Enrollment
675
Implantation of a RM Pressfit vitamys hip cup
Harris Hip Score (modified after Haddad et al, 1990)
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Time frame: 2 years
Radiographic evaluation
The second endpoint of interest is the occurence of osteolysis around the cup
Time frame: 6-12 weeks - 10 years
Adverse Events
Reporting of Adverse Events
Time frame: 6-12 weeks - 10 years
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