Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study

MicroPort

Status

Completed

Conditions

Osteoarthritis, Hip

Hip Disease

Hip Osteoarthritis

Joint Pain

Treatments

Device: Wright Medical Technology Metal-on-Metal Total Hip System

Study type

Observational

Funder types

Industry

Identifiers

NCT03450733

11LJH001

Details and patient eligibility

About

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 surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and > 8 years, since implantation.

Enrollment

173 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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:
1. non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. 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