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

NCT ID: NCT03450733

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2022-06-18

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 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.

Conditions

Osteoarthritis, Hip; Hip Disease; Hip Osteoarthritis; Joint Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Previously Implanted (Group 1)

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

Wright Medical Technology Metal-on-Metal Total Hip System

Intervention Type: DEVICE

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.

Control (Group 2)

Control, non-implanted subjects

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

Exclusion Criteria

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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TriWest Research Associates

El Cajon, California, United States

BioSolutions Research Center

La Mesa, California, United States

University of Iowa

Iowa City, Iowa, United States

Spokane Joint Replacement Center, Inc.

Spokane, Washington, United States

Countries

United States

Other Identifiers

11LJH001

Identifier Type: -

Identifier Source: org_study_id