NCT04079114

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Patients who received the Stafit Acetabular System	Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Timeline

• Start date: 2011-04-28
• Primary completion: 2017-01-24
• Completion: 2019-07-15
• First posted: 2019-09-06
• Last updated: 2020-06-30
• Results posted: 2020-06-30