Bespoke vs Standard Instrumentation in TKR

• Research type

  Research Study

• Full title

  Randomised controlled trial of patient-specific instrumentation vs standard instrumentation in total knee arthroplasty

• IRAS ID

  177817

• Contact name

  Leela Biant

• Contact email

  leela.biant@manchester.ac.uk

• Sponsor organisation

  Manchester University NHS Foundation Trust (MFT)

• Clinicaltrials.gov Identifier

  NCT02501733

• Duration of Study in the UK

  2 years, 4 months, 1 days

• Research summary

  Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a longer-lasting implant.
  This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.

• REC name

  South East Scotland REC 02

• REC reference

  15/SS/0058

• Date of REC Opinion

  27 Apr 2015

• REC opinion

  Further Information Favourable Opinion