PROFEMUR® L Revision Femoral Stem: Revision Total Hip Arthroplasty
Study summary
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Has undergone revision total hip arthroplasty
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments
Exclusion Criteria:
* Subjects currently enrolled in another clinical study
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
Primary outcome measure(s)
Number of participants who require a revision — 10 years post-operative The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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