NCT01859130

Zimmer POLAR - Total Knee Arthroplasty (TKA)

Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (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 measured by pain and function, quality of life data, radiographic parameters and survivorship.

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 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. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years. All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.

Conditions

• Osteoarthritis
• RheumatoId Arthritis
• Traumatic Arthritis
• Polyarthritis

Interventions

Type	Name	Description
DEVICE	Zimmer Persona Total Knee System

Timeline

• Start date: 2013-10-21
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2013-05-21
• Last updated: 2023-10-13
• Results posted: 2023-10-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study