MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.
Study Type
OBSERVATIONAL
Enrollment
52
THA using PROFEMUR® Xm Femoral Stems
St. Marien-Hospital Mülheim, Klinik für Orthopädie, Unfall & Wiederherstellungschirurgie
Mülheim, Germany
Component Survivorship
The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.
Time frame: 10 years post-operative
Patient functional outcomes (hip specific)
To characterize total functional scores, as assessed by Oxford Hip Scores
Time frame: Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
Patient functional outcomes (quality of life)
To characterize total functional scores, as assessed by EQ-5D-3L scores
Time frame: Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
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