Post Approval Study: NOVATION Ceramic Articulation Hip System
- Conditions
- Total Hip Replacement (Non-inflammatory)
- 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
- 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)
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
Hampton Roads Orthopaedics & Sports Medicine
🇺🇸Newport News, Virginia, United States
Shrock Orthopedic Research🇺🇸Fort Lauderdale, Florida, United States