The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.
This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study
Study Type
OBSERVATIONAL
Enrollment
199
Michael Bolognesi, MD
Durham, North Carolina, United States
Clinical success at Month 120
Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least "good" function/pain relief defined as Harris Hip Score ≥ 80.
Time frame: 10 years
Radiographic outcomes
Secondary measures: radiographic outcomes
Time frame: 10 years
Metal Ion (serum)
metal ion (serum) and renal function will also be collected.
Time frame: 24 months
Assessment for Adverse Events
Subjects will be assessed for any adverse events during their length of participation
Time frame: 10 years
Measurement of Patient Satisfaction
Patient satisfaction as assessed by the SF-12
Time frame: 10 years
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