G7 With Vivacit-E and Longevity Post-market Follow-up Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Avascular Necrosis of Hip
- Degenerative Joint Disease of Hip
- Fracture of Hip
- Fractures, Hip
- Osteoarthritis of Hip
- Osteoarthritis Hip
- Rheumatoid Arthritis of Hip
- Total Hip Arthroplasty
- 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 125 years
- Gender
- Both males and females
Description
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events...
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
Tracking Information
- NCT #
- NCT04754087
- Collaborators
- Not Provided
- Investigators
- Study Director: Kacy Arnold, MBA Zimmer Biomet
Get Well Soon