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NCT03450733 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by MicroPort Orthopedics.

Completed
Registry status
173
Enrollment target

NCT03450733 is a clinical trial that has completed, run by MicroPort Orthopedics. The registered enrollment target is 173 participants.

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The verdict

NCT03450733 has completed, sponsored by MicroPort Orthopedics.

COMPLETED
Registry status
173 participants
Enrollment target

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.

Interventions

  • DEVICE Wright Medical Technology Metal-on-Metal Total Hip System

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2018-04-11
Est. Completion 2022-06-18

Sponsor

MicroPort Orthopedics

7 total trials

What the Registry Record Tells You About NCT03450733

The ClinicalTrials.gov registry entry for NCT03450733 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MicroPort Orthopedics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Wright Medical Technology Metal-on-Metal Total Hip System is the first listed.

NCT03450733 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03450733 about?

NCT03450733 is a clinical study titled "Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study". 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, f...

What is the current status of trial NCT03450733?

This trial is currently completed. The enrollment target is 173 participants. The study started on 2018-04-11. Estimated completion is 2022-06-18.

What interventions are being tested in trial NCT03450733?

The interventions under investigation include: Wright Medical Technology Metal-on-Metal Total Hip System (DEVICE).

Who is sponsoring clinical trial NCT03450733?

This trial is sponsored by MicroPort Orthopedics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.