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

Zimmer Biomet

Status: Terminated

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

Treatments: Device: Patients who received the Stafit Acetabular System

Study type: Observational

Funder types: Industry

Identifiers

NCT04079114

09H07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design