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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: Completed study, sponsored by MicroPort Orthopedics.
NCT03450733 is a clinical trial that has completed, run by MicroPort Orthopedics. The registered enrollment target is 173 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)
Interventions
- DEVICE Wright Medical Technology Metal-on-Metal Total Hip System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2018-04-11 |
| Est. Completion | 2022-06-18 |
What the finished NCT03450733 record still lists
NCT03450733 is an observational study that tracks outcomes without assigning an intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap.
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 does not publish any study locations in the registry export this page uses.
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.
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