PHYSICA KR Clinical Trial

• Research type

  Research Study

• Full title

  A multicentre, prospective clinical study evaluating the outcomes of a new knee system with a physiological rollback mechanism.

• IRAS ID

  137766

• Contact name

  Adrian Harvey

• Contact email

  office@adrian-harvey.co.uk

• Sponsor organisation

  Limacorporate spa

• Research summary

  The PHYSICA KR study is an international, multi-centre clinical study. It will include patients who require surgery for a disease of the knee, including osteoarthritis and rheumatoid arthritis.
  The aim of the study is to assess the clinical, radiographic and patient-reported outcomes after total knee replacement.
  The study will enrol 156 patients across 3 sites (2 in the UK and 1 in Italy). Patients that are recruited into the study will return for follow-up visits at 6 weeks,6 months, 1 year, 2 year, 3 year and 5 years post-surgery.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  13/EE/0438

• Date of REC Opinion

  13 Feb 2014

• REC opinion

  Further Information Favourable Opinion