Post Approval Study: NOVATION Ceramic Articulation Hip System
- Conditions
- Total Hip Replacement (Non-inflammatory)
- Interventions
- Device: Novation Ceramic
- Registration Number
- NCT00715143
- Lead Sponsor
- Exactech
- Brief Summary
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").
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 126
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System Novation Ceramic All subjects will receive the Novation Ceramic on Ceramic Articulating Hip System.
- Primary Outcome Measures
Name Time Method Survivorship of device components Immediately post operation, 6 weeks, 6 months, annually 1-5 years Device Survivorship
Radiographic evaluation of radiolucency Immediately post operation, 6 weeks, 6 months, annually 1-5 years Radiographic analysis
Harris Hip Score Immediately post operation, 6 weeks, 6 months, annually 1-5 years Physician assessed outcome
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Hampton Roads Orthopaedics & Sports Medicine
🇺🇸Newport News, Virginia, United States
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