The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS").
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS"). Ten (10) years of follow-up data will be collected in this study. The first five (5) years of subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and self-assessment evaluation. The remaining five (5) years of subject follow-up will be accomplished with an outcomes questionnaire that will be completed by the subjects to evaluate the survivorship status of their hip replacement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
This treatment is the study device (which will be compared to a similar historic control device)
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States
Resurgens Orthopaedics
Cumming, Georgia, United States
Fallon Clinic
Worcester, Massachusetts, United States
Tulsa Bone & Joint Associates
Tulsa, Oklahoma, United States
Radiographic evaluation of radiolucency
Radiographic analysis
Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Survivorship of device components
Device Survivorship
Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Harris Hip Score
Physician assessed outcome
Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hampton Roads Orthopaedics & Sports Medicine
Newport News, Virginia, United States