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The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona fixed bearing implants used in primary total knee arthroplasty. The assessments will include: implant survivorship based on removal of a study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERSONA TKA | Other | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer Persona Total Knee System | Device | Primary Total Knee Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | Knee Society Score | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | EQ-5D | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | 80210 | United States | ||
| Orthopaedic & Spine Center of the Rockies |
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| Fort Collins |
| Colorado |
| 80525 |
| United States |
| Denver-Vail Orthopedics | Parker | Colorado | 80134 | United States |
| Rockford Orthopedic Associates | Rockford | Illinois | 61114 | United States |
| Henry County Orthopedics and Sports Medicine | New Castle | Indiana | 47362 | United States |
| UNC Department of Orthopaedics | Chapel Hill | North Carolina | 27599-7055 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Raleigh Orthopaedic Clinic | Raleigh | North Carolina | 27612 | United States |
| Lindner Research Center | Cincinnati | Ohio | 45219 | United States |
| SportsMedicine Grant & Orthopaedic Associates | Columbus | Ohio | 43215 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Tennessee Orthopaedic Foundation for Education and Research | Knoxville | Tennessee | 37930 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| Jordan Young Institute | Virginia Beach | Virginia | 23462-1784 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D056304 | Genu Valgum |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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