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The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ArComXL® polyethylene | ArComXL® polyethylene |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of revisions and removals | Patient questionnaire | Annually through 10 years |
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Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications
Relative contraindications
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Patients that have already made the decision to undergo Total Hip Replacement and will recieve ArComXL® polyethylene
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold, MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Orthopaedic Center | Rockville | Maryland | 20850 | United States | ||
| The Orthopaedic Institute of Ohio |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Lima |
| Ohio |
| 45804 |
| United States |
| Ohio Valley Orthopedic and Sports Medicine | West Chester | Ohio | 45069 | United States |
| Scranton Orthopaedic Specialists, PC | Dickson City | Pennsylvania | 18519 | United States |
| Texas Orthopedic Specialists, PA | Grapevine | Texas | 76051 | United States |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |