SUI vs. RUI

• Research type

  Research Study

• Full title

  Comparison of Alignment achieved using Single-Use versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation.

• IRAS ID

  184173

• Contact name

  Verdonna Huey

• Contact email

  vhuey@its.jnj.com

• Sponsor organisation

  DePuy Synthes Joint Reconstruction

• Duration of Study in the UK

  1 years, 2 months, 31 days

• Research summary

  This study has been designed to prospectively compare results of Attune® primary total knee arthroplasty implanted using either the Attune Single Use Instruments or Attune Reusable Instruments.
  Attune Single Use Instruments are pre-packed, sterile, single use, disposable surgical instruments.
  Attune reusable instruments go through the process of decontamination and re-sterilization before each surgical procedure.
  The Attune total knee arthroplasty, Attune Single Use Instruments and Attune Reusable Instruments are CE marked and approved for use in the UK.
  The study will determine if the knee alignment achieved with the Single Use Instruments is comparable to the knee alignment achieved with the Reusable Instruments. The study will compare radiographic outcomes as well as safety performance in both groups. 88 subjects (44 implanted with the Single Use Instruments, 44 implanted with the Reusable Instruments) with non-inflammatory degenerative joint disease resulting from osteoarthritis or post-traumatic arthritis aged 22-80 will be included in total worldwide.

  The anticipated recruitment period is 8 months for enrollment and 5 months for post-operative follow-up. Therefore the total duration is 13 months. For the purpose of the study the subjects will attend visits at pre-op, surgery and approximately 3 months post surgery. Demographic data will be collected preoperatively. Surgical data will be collected intraoperatively. During the 3 month visit subjects will have a set of x-rays taken (AP view, Lateral view and Long leg view). Following completion of the study, follow up care will be as per the standard care of their hospital.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  15/YH/0405

• Date of REC Opinion

  22 Oct 2015

• REC opinion

  Further Information Favourable Opinion