N/A
N=150
Avenir Müller Hip Stem Post Market Surveillance Study
Osteoarthritis, Hip · Rheumatoid Arthritis · Fracture of Hip · Dislocated Hip · Osteonecrosis
Bottom Line
View on ClinicalTrials.gov: NCT04079127 ↗Enrolled (actual)
150
Serious AEs
12.1%
Results posted
Jun 2020
Primary outcome: Primary: Evaluation of Pain and Functional Performance Determined by the Harris Hip Score — 90.9 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Pain and Functional Performance Determined by the Harris Hip Score |
90.9 | — |
| SECONDARY Confirmation of Safety Based on Complications |
10 | — |
| SECONDARY Survivorship of the Implant |
98.54 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04079127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.