At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem
In Brief
An observational study evaluating Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem. for Osteoarthritis, Hip and 6 related conditions. Completed, enrolled 150 participants.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis, Subluxation Hip
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
Primary CompletionJun 2019
Study CompletionAug 2019
First PostedSep 2019
TodayJul 2026
First PostedSep 6, 2019
Enrollment StartJan 9, 2010
Primary CompletionJun 29, 2019
Study CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 6.8 years ago
Interventions
Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.device
Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.