ODEP Surveillance study for the GENUS UNI Knee replacement

• Research type

  Research Study

• Full title

  Post Marketing Surveillance study for the GENUS UNI uni-compartmental Knee replacement

• IRAS ID

  155481

• Contact name

  Carlo Dottino

• Contact email

  cdottino@adlerortho.com

• Sponsor organisation

  Adler Ortho srl

• Research summary

  The study is a multi-centre and multi-surgeons observational study, looking at the survival-ship of the prosthesis in patients undergoing Uni-compartmental knee arthoplasty using the GENUS UNI over a 10 years follow up period.
  The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary Uni-compartmental knee arthoplasty using the GENUS UNI. In addition, improvement in patient’s quality of life (QOL)will be assessed using the Oxford and EuroQol knee patient outcomes questionnaires.
  
  Participants will be recruited through hospitals when they are put on the waiting list for Uni-compartmental knee replacement using the GENUS UNI implant. Participants will undergo normal treatment, but will be followed up after their operation at 6 weeks, 3 and 6 months and annually after that for 10 years. Study participants will be asked to complete Oxford and EQ-5D health questionnaires pre and post operatively at the designated time points. Radiographic examination will take place at 1, 3, 5 and 10 years postoperatively.
  

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  14/LO/1640

• Date of REC Opinion

  14 Oct 2014

• REC opinion

  Favourable Opinion