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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

To be included in Group 1, subjects must meet all of the following criteria: 1. Has been implanted with appropriate components of the WMT MOM THA System. 2. 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. 3. Is willing and able to complete required study visit(s) and assessments. 4. Plans to be available for the required study visit. 5. Is capable of providing sufficient blood for sampling according to blood draw procedures. 6. 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: 1. Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants. 2. Is not an employee of the Investigator. 3. Is willing and able to provide Informed Consent document. 4. Is willing and able to attend the requested study visit(s) and assessments. 5. 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: 1. Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol. 2. Subject is unwilling or unable to sign the Informed Consent document. 3. Subject has documented substance abuse issues. 4. Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study. 5. Subject is currently incarcerated or has impending incarceration. 6. Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator) 7. Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03450733
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MicroPort Orthopedics Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Hip, Hip Disease, Hip Osteoarthritis, Joint Pain

Arms & Interventions

Arms

: Previously Implanted (Group 1)

Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System

: Control (Group 2)

Control, non-implanted subjects

Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TriWest Research Associates, El Cajon, California

Status

Address

TriWest Research Associates

El Cajon, California, 92020

University of Iowa, Iowa City, Iowa

Status

Address

University of Iowa

Iowa City, Iowa, 52242

Spokane Joint Replacement Center, Inc., Spokane, Washington

Status

Address

Spokane Joint Replacement Center, Inc.

Spokane, Washington, 99208

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