A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
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|ClinicalTrials.gov Identifier: NCT00698152|
Recruitment Status : Unknown
Verified June 2015 by Zimmer Biomet ( Biomet Orthopedics, LLC ).
Recruitment status was: Active, not recruiting
First Posted : June 17, 2008
Last Update Posted : June 18, 2015
|Condition or disease|
|Osteoarthritis Avascular Necrosis Rheumatoid Arthritis|
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.
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
- Incidence of revisions and removals assessed by the use of a yearly survey mail to patient [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698152
|Study Director:||Russell Schenck, PhD||Clinical Research, Biomet Orthopedics, Inc.|