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: Completed study, sponsored by Zimmer Biomet.
NCT00565786 is a clinical trial that has completed, run by Zimmer Biomet. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Independent wear analysis of radiographs. The six-week radiographic evaluation will be assessed in comparison to the one-year evaluation in order to determine the early changes of the polyethylene. The difference between the one and two-year evaluations will yield the first true wear rate. We have included a three-year evaluation to reduce the scatter of the linear regression used to calculate the wear rate. The five-year and ten-year evaluations will produce mid and long-term wear rates.
Interventions
- DEVICE ArCom® Polyethylene
- DEVICE ArComXL® Polyethylene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-07 |
| Est. Completion | 2020-01-13 |
What the finished NCT00565786 record still lists
NCT00565786 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which ArCom® Polyethylene is the first listed.
NCT00565786 does not publish any study locations in the registry export this page uses.
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia