Exception Cementless Hip Stem
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Avascular Necrosis of Hip
- Congenital Hip Dysplasia
- Femoral Neck Fractures
- Inflammatory Arthritis
- Osteoarthritis Hip
- Rheumatoid Arthritis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Other
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. This study is an extension of ...
Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively. Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it. Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.
Tracking Information
- NCT #
- NCT04349046
- Collaborators
- Not Provided
- Investigators
- Study Director: Hassan Achakri Zimmer Biomet