NCT03672916

Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty

Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, non-controlled post market surveillance study. 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.

Detailed 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 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 are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.

Conditions

• Avascular Necrosis of Hip
• Osteoarthritis, Hip
• Inflammatory Arthritis
• Post-Traumatic Osteoarthritis of Hip

Timeline

• Start date: 2011-05-01
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2018-09-17
• Last updated: 2025-02-12
• Results posted: 2025-02-12

Locations

4 sites across 2 countries: Germany, Sweden