CAPAbility

• Research type

  Research Study

• Full title

  Comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II Total Knee Arthroplasty in Performance and functional ABILITY. A Randomised Controlled Trial

• IRAS ID

  221875

• Contact name

  Iain McNamara

• Contact email

  iain.mcnamara@nnuh.nhs.uk

• Sponsor organisation

  Norfolk and Norwich University Hosptials NHS Foundation Trust

• Duration of Study in the UK

  1 years, 11 months, 1 days

• Research summary

  This study is designed to look at whether a newer type of knee replacement joint which has been designed to provide improved kinematic (motion of joint) outcomes will improve patient’s experiences following total knee replacement(TKR) surgery.
  Osteoarthritis of the knee is a common musculoskeletal condition which is expected to significantly increase during the next two decades as the incidence of obesity and ageing rises. Total Knee replacement is undertaken for this condition in patients who do not respond to other treatments. Evidence suggests that up to 34% of patients have poor outcomes following their knee replacement which put patients at risk of not being able to exercise or undertake physical activity. This can mean that they are more prone to conditions such as diabetes and cardiovascular disease. This is important to patients and also puts a significant burden on the NHS.
  Current evidence relating to outcomes is based on patient reported outcomes and there is no evidence about the relationship with kinematic outcomes. Correct alignment of the knee has also been assumed to be important but, there are no studies which examine this further.
  This trial will compare patient reported, clinical, kinematic and radiological outcomes for two different types of knee replacement joint. Patients will receive one of the two joints and will be followed up for 6 months following surgery. There will be interviews to examine patients, surgeons and physiotherapists views of the operation, recovery and rehabilitation.
  Patients will be recruited from the Norfolk and Norwich University Hospital with some of the operations taking place at Spire Norwich. Assessments will also take place in a specialist movement laboratory at the University of East Anglia. Patients will be recruited up to 4 months prior to their surgery and the final assessment will take place 6 months after surgery

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  17/EE/0230

• Date of REC Opinion

  27 Jul 2017

• REC opinion

  Further Information Favourable Opinion