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

NCT03450733 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 173

Last updated 2022-10-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MicroPort Orthopedics Inc.

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2021-11-24
Completion
2022-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450733 on ClinicalTrials.gov