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NCT01657435 · ClinicalTrials.gov registry record
28mm Ceramic-on-Ceramic Total Hip Replacement Study
A clinical trial, sponsored by DePuy Orthopaedics.
- Terminated
- Registry status
- 185
- Enrollment target
NCT01657435: Clinical Trial study, sponsored by DePuy Orthopaedics.
NCT01657435 is a clinical trial that was terminated before completion, run by DePuy Orthopaedics. The registered enrollment target is 185 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657435 was terminated before completion, sponsored by DePuy Orthopaedics.
- TERMINATED
- Registry status
- 185 participants
- Enrollment target
Study Summary
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase. In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually. In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.
Primary Outcome
The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence \[NICE\]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.
Interventions
- DEVICE Ceramax Acetabular System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2012-05-01 |
| Est. Completion | 2019-09-24 |
Why NCT01657435 stopped before completion
NCT01657435 is an observational study that tracks outcomes without assigning an intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Ceramax Acetabular System is the first listed.
NCT01657435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01657435 about?
NCT01657435 is a clinical study titled "28mm Ceramic-on-Ceramic Total Hip Replacement Study". This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phas...
What is the current status of trial NCT01657435?
This trial is currently terminated. The enrollment target is 185 participants. The study started on 2012-05-01. Estimated completion is 2019-09-24.
What interventions are being tested in trial NCT01657435?
The interventions under investigation include: Ceramax Acetabular System (DEVICE).
Who is sponsoring clinical trial NCT01657435?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
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