Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00565786 · ClinicalTrials.gov registry record
ArCom® and ArComXL® Polyethylene Data Collection
A clinical trial, sponsored by Zimmer Biomet.
- Completed
- Registry status
- 150
- Enrollment target
NCT00565786 is a clinical trial that has completed, run by Zimmer Biomet. The registered enrollment target is 150 participants.
The verdict
NCT00565786 has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies. Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol.
Interventions
- DEVICE ArCom® Polyethylene
- DEVICE ArComXL® Polyethylene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-07 |
| Est. Completion | 2020-01-13 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00565786
The ClinicalTrials.gov registry entry for NCT00565786 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ArCom® Polyethylene is the first listed.
NCT00565786 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00565786 about?
NCT00565786 is a clinical study titled "ArCom® and ArComXL® Polyethylene Data Collection". The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engin...
What is the current status of trial NCT00565786?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2004-07. Estimated completion is 2020-01-13.
What interventions are being tested in trial NCT00565786?
The interventions under investigation include: ArCom® Polyethylene (DEVICE), ArComXL® Polyethylene (DEVICE).
Who is sponsoring clinical trial NCT00565786?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.