Persona Partial Knee Clinical Outcomes Study

Osteoarthritis Clinical Trial

Official title: Persona Partial Knee Clinical Outcomes Study

Status Active, not recruiting

Clinical Trial Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Conditional Revision of the Articular Surface
• Conditional Tibial Condyle or Plateau Fractures
• Necrosis
• Osteoarthritis
• Traumatic Arthritis

• NCT number: NCT03034811
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2017
• Completion date: July 2029