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NCT00208494 · ClinicalTrials.gov registry record · NA
Metal on Metal Versus Ceramic on Metal Hip Replacement
A NA study, sponsored by DePuy Orthopaedics.
- Completed
- Registry status
- NA
- Development phase
- 392
- Enrollment target
NCT00208494: Completed NA study, sponsored by DePuy Orthopaedics.
NCT00208494 is a NA study that has completed, run by DePuy Orthopaedics. The registered enrollment target is 392 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00208494, a NA study, has completed, sponsored by DePuy Orthopaedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 392 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
Primary Outcome
The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/\< 2mm, acetabular migration =/\< 2mm, cup inclination =/\< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint i
Interventions
- DEVICE Total Hip Replacement
- DEVICE Total hip replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2005-08 |
| Est. Completion | 2011-06 |
| Phase | NA |
What the finished NCT00208494 record still lists
NCT00208494 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Total Hip Replacement is the first listed.
NCT00208494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00208494 about?
NCT00208494 is a clinical study titled "Metal on Metal Versus Ceramic on Metal Hip Replacement". The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiogra...
What is the current status of trial NCT00208494?
This trial is currently completed. It is a NA study. The enrollment target is 392 participants. The study started on 2005-08. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00208494?
The interventions under investigation include: Total Hip Replacement (DEVICE), Total hip replacement (DEVICE).
Who is sponsoring clinical trial NCT00208494?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00208494's enrollment target sits among peer trials
392 269th of 2000 higher than 1,732 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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