A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement|
- Incidence of revisions and removals assessed by the use of a yearly survey mail to patient [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698152
|Study Director:||Russell Schenck, PhD||Clinical Research, Biomet Orthopedics, Inc.|