An observational study in Joint Disease, sponsored by MicroPort Orthopedics Inc.. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by MicroPort Orthopedics Inc. (part of MicroPort Scientific Corporation) · Observational
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.
716 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 26 is below the median of 100 across 217 observational studies indexed under Joint Diseases.
Browse Joint Diseases studies →MicroPort Orthopedics Inc. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
First submitted after MicroPort Orthopedics Inc. became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Patients who have been previously implanted with PROFEMUR® L Revision Femoral Components
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Exclusion Criteria:
Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem
Device: PROFEMUR® L Revision Femoral Stem
Revision Total Hip Arthroplasty
Also known as: Hip Revision Device
Number of participants who require a revision
The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.
Time frame: 10 years post-operative
Patient functional score on the the Oxford Hip Score instrument
To characterize patient hip-related health status, as assessed by Oxford Hip Scores
Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Patient functional score on the EQ-5D-3L instrument
To characterize patient general health status, as assessed by EQ-5D-3L scores
Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Plan to share: No
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This study is active, not recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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