Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System

Rheumatoid Arthritis Clinical Trial

Official title: Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study

Status Terminated

Clinical Trial Summary

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

Clinical Trial Description

The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.

Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.

The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System. ;

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Dislocated Hip
• Fracture of Hip
• Hip Fractures
• Joint Diseases
• Necrosis
• Osteoarthritis, Hip
• Osteonecrosis
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis
• Subluxation Hip

• NCT number: NCT04079114
• Study type: Observational
• Source: Zimmer Biomet
• Status: Terminated
• Start date: April 28, 2011
• Completion date: July 15, 2019