A Post Market Clinical Follow-up Study With the aneXys Cup

Status Active, not recruiting

Clinical Trial Summary

The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Clinical Trial Description

Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 100 patients in 3 clinics will be included. In each clinic 10-57 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study. Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating. ;

Study Design

Related Conditions & MeSH terms

Arthroplasty, Replacement, Hip

Clinical Trial Details

NCT number	NCT03274830
Study type	Observational
Source	Mathys Ltd Bettlach
Contact
Status	Active, not recruiting
Phase
Start date	March 5, 2020
Completion date	September 2034

View Details

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