NCT02346513|Unknown
Serum Level of Cobalt and Chromium After Ceramic on Metal Articulation Total Hip Arthroplasty
CoM
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CoM
Sponsor study identifier
observational
228
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 24, 2014
Actual (reported)January 27, 2015
Actual (reported)May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Serum metal ion analysis
Blood sampling will be performed 2 times during follow-up outpatient clinic visits. Second sampling is performed 3 months after first sampling.
6 months
Wear Measure
6 months
Radiographic evaluation
6 months
WOMAC score
6 months
Harris Hip score
6 months
UCLA activity score
6 months
Subgroup A1: Consist of ceramic on metal THAs with short term follow-up (less than 2years) Subgroup A2: Consist of ceramic on metal THAs with midterm follow-up (more than 2years) Subgroup A3: Consist of bilateral ceramic on metal THAs
Patients have THA with non COM bearing
Patients without any implant or systemic disease, to served as controls
Patients have THA with ceramic on metal articulation
Patients have THA with non-ceramic on metal articulation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The patient population is being drawn for patients seen in the orthopedics department from (April. 2009 -December 2012) patients are selected based on implant type then further selection is based on inclusion and exclusion criteria. Exclusion criteria are specifically selected to exclude any pathologies, or environmental factors that would confound the study population. Once patients are initially selected they are contacted for participation and brought in for screening. Enrollment proceeds until enough patients have been recruited to meet statistical criteria and provide sufficient study power.
Korea University Guro Hospital
Seoul, KS013, South Korea
Won Yong Shon, Professor
Korea University Guro Hospital
First Submitted
November 24, 2014
First Posted
January 27, 2015
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Functional Movement Retraining After Hip Replacement
Contact the study team to confirm eligibility.
May 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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