Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (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 (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, 5, 7 and 10 years post-operatively.
Specific assessments include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Cementless Femur Cementless Tibia |
| |
| Cohort 2 | Cementless Femur Cementless Tibia |
| |
| Cohort 3 | Cemented Femur Cemented Tibia |
| |
| Cohort 4 | Cemented Femur Cemented Tibia |
| |
| Cohort 5 | Cementless Femur Cemented Tibia |
| |
| Cohort 6 | Cementless Femur Cemented Tibia |
| |
| Cohort 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Device | Total knee replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (OKS) | A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure | A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health. | 5 years |
| Pain and Satisfaction Numeric Rating Scale (NRS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Hip & Knee, Inc. | Parker | Colorado | 80138 | United States | ||
| Foundation for Orthopaedic Research & Education |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cementless Femur Cemented Tibia
|
| Cohort 8 | Cementless Femur Cemented Tibia |
|
| Cohort 9 | Cementless Femur Cementless Tibia |
|
| Cohort 10 | Cementless Femur Cementless Tibia |
|
| Cohort 11 | Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10. |
|
| Cohort 12 | Cementless Femur Cementless Tibia Cementless Patella |
|
Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied". |
| 5 years |
| Tampa |
| Florida |
| 33607 |
| United States |
| Northside Hospital, Inc. | Atlanta | Georgia | 30342 | United States |
| U of L Health | Louisville | Kentucky | 40202 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Mississippi Sports Medicine and Orthopaedic Center | Jackson | Mississippi | 39202 | United States |
| New Mexico Orthopaedic Associates | Albuquerque | New Mexico | 87110 | United States |
| Syracuse Orthopaedic Specialists | DeWitt | New York | 13214 | United States |
| NYU | New York | New York | 11016 | United States |
| St. Francis Hospital & Heart Center | Roslyn | New York | 11576 | United States |
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | 28207 | United States |
| Duke University | Morrisville | North Carolina | 27560 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| UT Health at Houston | Houston | Texas | 77030 | United States |
| UVA Health Orthopedic Center | Charlottesville | Virginia | 22903 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D010020 | Osteonecrosis |
| D010003 | Osteoarthritis |
| 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 |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| 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 |
Not provided
Not provided