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

NCT ID: NCT04079114

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-28
• Study Completion Date: 2019-07-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males and females
• Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
• 18 years minimum
• Patients able to participate in a follow-up program based upon physical examination and medical history
• Patients who have provided written informed consent by signing the Patient Informed Consent Form.

Exclusion Criteria

• Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
• Known pregnancy
• Revision hip arthroplasty

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Vivoda

Role: STUDY_DIRECTOR

Zimmer Biomet

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09H07

Identifier Type: -

Identifier Source: org_study_id