Persona Total Knee Arthroplasty Outcomes Study

Rheumatoid Arthritis Clinical Trial

Official title: Persona The Personalized Knee System TKA Outcomes Study: Prospective Multicenter Study of the Persona Knee System

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis of the Femoral Condyle
• Knee Pain Chronic
• Moderate Varus, Valgus or Flexion Deformities
• Necrosis
• Osteoarthritis
• Polyarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

• NCT number: NCT02255383
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2014
• Completion date: December 2027