NCT03672370

PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty

Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.

Detailed description

The objectives of this study are to obtain survival and outcomes data on the Alloclassic® Variall® Cup in combination with the BIOLOX® delta Taper Liner and a BIOLOX® delta Femoral Head used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.

Conditions

• Avascular Necrosis
• Osteoarthritis
• Inflammatory Arthritis
• Posttraumatic Arthritis

Timeline

• Start date: 2015-03-24
• Primary completion: 2019-05-14
• Completion: 2020-05-01
• First posted: 2018-09-14
• Last updated: 2021-01-14
• Results posted: 2021-01-14

Locations

2 sites across 1 country: Austria