The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
Study Type
OBSERVATIONAL
Enrollment
52
Primary total hip arthroplasty
South Bend Orthopaedics
South Bend, Indiana, United States
Survival of the Implant System via Adverse Events
The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.
Time frame: 10 years
Pain and functional performance measured by the Oxford Hip Score
The Oxford Hip Score measures pain and function together, reflecting how hip symptoms impact a patient's severity and frequency of hip-related pain and their physical capabilities.
Time frame: 10 years
Subject quality-of-life measured by the EQ-5D-5L
The EQ-5D-5L is a standardized questionnaire that measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides an overall assessment of a participant's perceived health status.
Time frame: 10 Years
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