NCT00698152

A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

Detailed description

Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected. This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Conditions

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis

Timeline

• Start date: 2006-01-23
• Primary completion: 2016-01-15
• Completion: 2016-01-15
• First posted: 2008-06-17
• Last updated: 2020-03-30

Locations

5 sites across 1 country: United States