NCT04322916

Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 675 (actual)
• Sponsor: Mathys Ltd Bettlach · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study. The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.

Conditions

• Arthropathy of Hip
• Hip Replacement

Interventions

Type	Name	Description
DEVICE	RM Pressfit vitamys	Implantation of a RM Pressfit vitamys hip cup

Timeline

• Start date: 2009-09-15
• Primary completion: 2012-03-28
• Completion: 2022-04-01
• First posted: 2020-03-26
• Last updated: 2020-03-30