Vivacit-E Post-market Follow-up Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Avascular Necrosis of Bone of Hip
- Congenital Hip Dysplasia
- Osteoarthritis
- Post-traumatic; Arthrosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Li...
Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell. In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear by the Martell 2-D method at 6 weeks and 1, 2, 4, & 5 years postoperatively. Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.
Tracking Information
- NCT #
- NCT03226808
- Collaborators
- Not Provided
- Investigators
- Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
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