Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Avascular Necrosis of Hip
- Inflammatory Arthritis
- Osteoarthritis Hip
- Post-Traumatic Osteoarthritis of Hip
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be u...
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System. A total of 200 patients will be enrolled in this study that will last 12 years (2 year enrollment plus 10 years follow-up) with the following visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
Tracking Information
- NCT #
- NCT03672916
- Collaborators
- Not Provided
- Investigators
- Study Director: Paola Vivoda Zimmer Biomet
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