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The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium 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. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively.
The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Specific assessments include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona Ti-Nidium | Other | Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer Biomet Persona Ti-Nidium Total Knee System | Device | Primary Knee Total Arthroplasty |
|
| 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) Expectations (pre and post op) | This is a 3 question form regarding a patient's expectations of the total knee replacement. The pre-op form assesses the patient's expectations of the knee replacement, and the post-op form addresses how the replacement is meeting said expectations. The score ranges from 3-15, with higher scores indicating a better outcome. | 10 years |
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Inclusion Criteria:
Study Device Inclusion Criteria:
The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
Exclusion Criteria:
Study Device Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet Assoc Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Hip & Knee, Inc. | Parker | Colorado | 80134 | United States | ||
| MedStar Health Research Institute |
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| 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. | 10 years |
| Hyattsville |
| Maryland |
| 20782 |
| United States |
| Mississippi Sports Medicine and Orthopaedic Center | Jackson | Mississippi | 39202 | United States |
| New Mexico Orthopaedic Associates | Albuquerque | New Mexico | 87110 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Monument Health Rapid City Hospital, Inc. | Rapid City | South Dakota | 57701 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D010020 | Osteonecrosis |
| 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 |
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