CompletedNot Applicable

Avenir Müller Hip Stem Post Market Surveillance Study

150 participantsStarted 2010-01-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Evaluation of Pain and Functional Performance Determined by the Harris Hip Score

Timeframe: 10 years

Trial details

NCT IDNCT04079127

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-06-29

Results submitted2020-04-15

View on ClinicalTrials.gov More Osteoarthritis, Hip trials