- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03450733
Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study
Post-Market Surveillance of the Wright Medical Technology Metal-on-Metal Total Hip System (FDA 522 Order)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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El Cajon, California, United States, 92020
- Triwest Research Associates
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La Mesa, California, United States, 91942
- BioSolutions Research Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Washington
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Spokane, Washington, United States, 99208
- Spokane Joint Replacement Center, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Group 1: Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System
Group 2: Control, non-implanted subjects
Description
Inclusion Criteria:
To be included in Group 1, subjects must meet all of the following criteria:
- Has been implanted with appropriate components of the WMT MOM THA System
Has previously undergone primary THA for any of the following:
- non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity.
- Is willing and able to complete required study visit(s) and assessments
- Plans to be available for the required study visit
- Is capable of providing sufficient blood for sampling according to blood draw procedures
- Is willing to sign the approved Informed Consent document
Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4) the subject agrees to a second Informed Consent document and data collection specific to the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted in this study.
To be included in Group 2, subjects must meet all of the following criteria:
- Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants
- Is not an employee of the Investigator
- Is willing and able to provide Informed Consent document
- Is willing and able to attend the requested study visit(s) and assessments
- Is capable of providing sufficient blood for sampling according to blood draw procedures
Exclusion Criteria:
Subjects will be excluded from either study group if they meet any of the following criteria:
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject is currently incarcerated or has impending incarceration
- Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator)
- Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Previously Implanted (Group 1)
Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System
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Subjects in Group 1 previously implanted prior to the study start date will be identified from Investigator records.
Collected data will be evaluated in aggregate and cross-sectioned by year of implantation.
Subjects will be cross-sectioned by the time that has elapsed between implantation and the initial visit (e.g. 5 years, 6 years) using contiguous visit windows (number of years + 6 months).
Subject data will be grouped in order to create cross-sectional epochs of ≤ 8 years and > 8 years.
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Control (Group 2)
Control, non-implanted subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Adverse Local Tissue Reactions (ALTR)
Time Frame: ≤ 8 years and > 8 years, since implantation
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To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)
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≤ 8 years and > 8 years, since implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine chromium and cobalt whole blood and serum ion levels across time intervals
Time Frame: ≤ 8 years and > 8 years, since implantation
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Cobalt and chromium metal ion levels will be measured in whole blood and serum from subjects implanted with the WMT MoM THA System (Group 1) at each defined cross-section interval.
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≤ 8 years and > 8 years, since implantation
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Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals
Time Frame: ≤ 8 years and > 8 years, since implantation
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Analyze difference in chromium and cobalt whole blood and serum ion levels in subjects implanted with the WMT MoM THA System (Group 1) versus control subjects (Group 2) cross-sectionally.
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≤ 8 years and > 8 years, since implantation
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Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).
Time Frame: ≤ 8 years and > 8 years, since implantation
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Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR
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≤ 8 years and > 8 years, since implantation
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Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).
Time Frame: ≤ 8 years and > 8 years, since implantation
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Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR
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≤ 8 years and > 8 years, since implantation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11LJH001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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