POLAR - TKA Study

• Research type

  Research Study

• Full title

  Persona™ Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA Study)

• IRAS ID

  147851

• Contact name

  Nick London

• Contact email

  njlondon@gmail.com

• Sponsor organisation

  Biomet UK Healthcare Ltd

• Research summary

  This study is performed to obtain clinical performance (outcomes) data and survivorship for commercially available Zimmer Persona knee implants implanted in
  primary total knee arthroplasty. This will be done by analysis of validated outcome
  measurement tools, radiographs and adverse event data.
  The study is prospective, multicenter, non-controlled. Up to 12 EMEA sites will contribute to this study with a maximum of 600 implanted knees.
  Each Investigator will offer study participation to each consecutive patient presenting as a candidate for primary total knee arthroplasty using the commercially available (CE marked and FDA cleared) Zimmer Persona knee implants and satisfying Inclusion/Exclusion criteria.
  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 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years post-operative.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  14/YH/0140

• Date of REC Opinion

  17 Jul 2014

• REC opinion

  Further Information Favourable Opinion