Status:
COMPLETED
Avenir Müller Hip Stem Post Market Surveillance Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis, Hip
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- Patients who are unwilling or unable to comply with the follow-up program.
- Known pregnancy.
- Patients who are skeletally immature.
Key Trial Info
Start Date :
January 9 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04079127
Start Date
January 9 2010
End Date
August 31 2019
Last Update
May 14 2021
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