Status:
COMPLETED
Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Osteoarthritis, Hip
Hip Disease
Eligibility:
All Genders
21+ years
Brief Summary
This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 18 2022
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT03450733
Start Date
April 11 2018
End Date
June 18 2022
Last Update
October 13 2022
Active Locations (4)
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1
TriWest Research Associates
El Cajon, California, United States, 92020
2
BioSolutions Research Center
La Mesa, California, United States, 91942
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Spokane Joint Replacement Center, Inc.
Spokane, Washington, United States, 99208