Trials / Active Not Recruiting
Active Not RecruitingNCT04817969
Persona Ti-Nidium Post-Market Clinical Follow-up
Persona® Ti-Nidium® Personalized Total Knee System A Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data Using the Persona Ti-Nidium Total Knee System and Instrumentation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Detailed description
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: 1. Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium total knee system and instrumentation in primary and revision TKA. 2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).
Conditions
- Knee Pain Chronic
- Osteoarthritis
- Rheumatoid Arthritis
- Traumatic Arthritis
- Polyarthritis
- Varus Deformity
- Valgus Deformity
- Flexion Deformity of the Knee
- Avascular Necrosis
- Patellofemoral Osteoarthritis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Zimmer Biomet Persona Ti-Nidium Total Knee System | Primary Knee Total Arthroplasty |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2034-05-01
- Completion
- 2034-05-01
- First posted
- 2021-03-26
- Last updated
- 2025-10-24
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04817969. Inclusion in this directory is not an endorsement.