NCT00565786

ArCom® and ArComXL® Polyethylene Data Collection

A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations.

Conditions

• Osteoarthritis of Hip

Interventions

Type	Name	Description
DEVICE	ArCom® Polyethylene	Argon packaged compression molded polyethylene
DEVICE	ArComXL® Polyethylene	Highly crosslinked Ultra High Molecular Weight Polyethylene

Timeline

• Start date: 2004-07-01
• Primary completion: 2017-01-17
• Completion: 2020-01-13
• First posted: 2007-11-30
• Last updated: 2025-06-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study