Zimmer POLAR - Total Knee Arthroplasty (TKA)

RheumatoId Arthritis Clinical Trial

Official title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty

Status Completed

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 measured by pain and function, quality of life data, radiographic parameters and survivorship.

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 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. ;

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Polyarthritis
• RheumatoId Arthritis
• Traumatic Arthritis

• NCT number: NCT01859130
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Completed
• Phase: N/A
• Start date: October 21, 2013
• Completion date: December 31, 2021