An observational study in Joint Disease, sponsored by MicroPort Orthopedics Inc.. Withdrawn at 1 site in France. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-06-07.
Sponsored by MicroPort Orthopedics Inc. · Observational
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
Browse Joint Diseases studies →MicroPort Orthopedics Inc. is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have been previously implanted with a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component
Subject has undergone primary THA for any of the following:
Exclusion Criteria:
Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component
Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell
PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component
Component Survivorship
The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.
Time frame: 10 years post-operative
Patient functional outcomes (hip specific)
To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores
Time frame: Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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MicroPort Orthopedics Inc.