An interventional study of Novation Ceramic in Total Hip Replacement (Non-inflammatory), sponsored by Exactech. Terminated at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by Exactech · Not applicable, Interventional, and Treatment
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 126 is above the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Exactech is the lead sponsor of 17 studies on the registry; 9 are open to participants now.
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Exclusion Criteria
All subjects will receive the Novation Ceramic on Ceramic Articulating Hip System.
Device: Novation Ceramic
This treatment is the study device (which will be compared to a similar historic control device)
Also known as: Novation
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 study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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