Trials / Active Not Recruiting
Active Not RecruitingNCT02255383
Persona Total Knee Arthroplasty Outcomes Study
Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 737 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Knee Pain Chronic
- Osteoarthritis
- Rheumatoid Arthritis
- Traumatic Arthritis
- Polyarthritis
- Moderate Varus, Valgus or Flexion Deformities
- Avascular Necrosis of the Femoral Condyle
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Zimmer Persona Total Knee System | Primary Total Knee Arthroplasty |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2025-12-01
- Completion
- 2027-12-01
- First posted
- 2014-10-02
- Last updated
- 2026-03-10
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02255383. Inclusion in this directory is not an endorsement.