Persona Partial Knee Clinical Outcomes Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 600
Summary
- Conditions
- Avascular Necrosis
- Conditional Revision of the Articular Surface
- Conditional Tibial Condyle or Plateau Fractures
- Osteoarthritis
- Traumatic Arthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. 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...
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. 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 partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively. The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the 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.
Tracking Information
- NCT #
- NCT03034811
- Collaborators
- Not Provided
- Investigators
- Study Director: Kacy Arnold, RN, MBA Zimmer Biomet