Trials / Completed
CompletedNCT04079127
Avenir Müller Hip Stem Post Market Surveillance Study
A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 Avenir Müller Hip Stem.
Detailed 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.
Conditions
- Osteoarthritis, Hip
- Rheumatoid Arthritis
- Fracture of Hip
- Dislocated Hip
- Osteonecrosis
- Post-traumatic; Arthrosis
- Subluxation Hip
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem. | Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem. |
Timeline
- Start date
- 2010-01-09
- Primary completion
- 2019-06-29
- Completion
- 2019-08-31
- First posted
- 2019-09-06
- Last updated
- 2021-05-14
- Results posted
- 2020-06-23
Source: ClinicalTrials.gov record NCT04079127. Inclusion in this directory is not an endorsement.