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NCT01884532 · ClinicalTrials.gov registry record
ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
A clinical trial, sponsored by DePuy Orthopaedics.
- Completed
- Registry status
- 146
- Enrollment target
NCT01884532: Completed study, sponsored by DePuy Orthopaedics.
NCT01884532 is a clinical trial that has completed, run by DePuy Orthopaedics. The registered enrollment target is 146 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01884532 has completed, sponsored by DePuy Orthopaedics.
- COMPLETED
- Registry status
- 146 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.
Primary Outcome
To compare the chromium serum ion levels in the patient population from pre-operatively through 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.
Interventions
- DEVICE ASR-XL Metal-on-Metal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-08 |
What the finished NCT01884532 record still lists
NCT01884532 is an observational study that tracks outcomes without assigning an intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which ASR-XL Metal-on-Metal is the first listed.
NCT01884532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01884532 about?
NCT01884532 is a clinical study titled "ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study". The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.
What is the current status of trial NCT01884532?
This trial is currently completed. The enrollment target is 146 participants. The study started on 2013-05. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01884532?
The interventions under investigation include: ASR-XL Metal-on-Metal (DEVICE).
Who is sponsoring clinical trial NCT01884532?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
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