Avenir Müller Hip Stem Post Market Surveillance Study

Zimmer Biomet

Status: Completed

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

Treatments: Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.

Study type: Observational

Funder types: Industry

Identifiers

NCT04079127

09H08

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 Avenir Müller Hip Stem.

Full description

The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients able to participate in a follow-up program based upon physical examination and medical history.
• Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
• 18 years minimum.
• Male and female.
• Baseline data exist (pre-, peri- and immediate postoperative)

Exclusion criteria

• Patients who are unwilling or unable to comply with the follow-up program.
• Known pregnancy.
• Patients who are skeletally immature.

Trial design

150 participants in 1 patient group

Patients suffering from severe hip pain and disability

Description:

Patients in need of a total hip arthroplasty.

Treatment:

Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.