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NCT00820443 · ClinicalTrials.gov registry record · Phase 4
Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial
A Phase 4 study, sponsored by MicroPort Orthopedics.
- Terminated
- Registry status
- Phase 4
- Development phase
- 253
- Enrollment target
NCT00820443: Clinical Trial Phase 4 study, sponsored by MicroPort Orthopedics.
NCT00820443 is a Phase 4 study that was terminated before completion, run by MicroPort Orthopedics. The registered enrollment target is 253 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00820443, a Phase 4 study, was terminated before completion, sponsored by MicroPort Orthopedics.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 253 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.
Primary Outcome
The patient success definition is measured at the 24 month interval by the following: * Harris Hip Score (HHS) of \> 80 • \< 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain. * No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure. A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will
Interventions
- DEVICE Ceramic on metal prosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2007-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
Why NCT00820443 stopped before completion
NCT00820443 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 1 intervention - of which Ceramic on metal prosthesis is the first listed.
NCT00820443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00820443 about?
NCT00820443 is a clinical study titled "Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial". The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.
What is the current status of trial NCT00820443?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 253 participants. The study started on 2007-06. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00820443?
The interventions under investigation include: Ceramic on metal prosthesis (DEVICE).
Who is sponsoring clinical trial NCT00820443?
This trial is sponsored by MicroPort Orthopedics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00820443's enrollment target sits among peer trials
253 339th of 2000 higher than 1,662 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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