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ArCom® and ArComXL® Polyethylene Data Collection

NCT00565786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-06-11

No results posted yet for this 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.

Conditions

  • Osteoarthritis of Hip

Interventions

DEVICE

ArCom® Polyethylene

Argon packaged compression molded polyethylene

DEVICE

ArComXL® Polyethylene

Highly crosslinked Ultra High Molecular Weight Polyethylene

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Kacy Arnold, MBA · Zimmer Biomet

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2017-01-17
Completion
2020-01-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00565786 on ClinicalTrials.gov