ATTUNE VS DEPUY PFC TKR. A RANDOMISED CONTROLLED TRIAL

• Research type

  Research Study

• Full title

  A Comparison of Clinical Outcomes of Patients undergoing a Total Knee Replacement with the ATTUNE or DEPUY PFC Total Knee Replacement. A Blinded Randomised Controlled Trial

• IRAS ID

  160047

• Contact name

  Tim Board

• Contact email

  tim.board@wwl.nhs.uk

• Sponsor organisation

  Wrightington Wigan and Leigh NHS Foundation Trust

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  Summary of Research
  Total Knee Replacement is a successful procedure with >95% satisfaction and success rates. There are several different types of Knee Implants which are on the market for use in Total Knee Replacement. Currently in Wrightington Hospital, the Depuy PFC Knee Replacement system is being used for Primary Total Knee Replacement surgeries. Recently a new type of Knee Replacement, the ATTUNE Knee, has been marketed as having greater short term functional outcomes than devices that are currently on the market for patients of all ages. We aim to investigate whether the new knee replacement system is superior to ones currently available in terms of patient outcomes.

  Summary of Results
  We compared the post operative clinical outcomes of patients undergoing Total Knee Replacement with either the PFC or Attune Total Knee Replacement systems.

  No difference in outcome was noted between the two implants at any time point.

  The statistical analysis found the Attune knee replacement was not inferior in outcomes compared to the PFC Knee Replacement.
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZKm4C0TeSkP8lYcMVEmwG5bmIi-2BKPwMPcwf9EtAQ0ect1DqTkV9kEU0bDAa0e-2B73CXXv95-2ByIUlsgXeAKZIna1fFrdkclZeHo2acgW1JTvCuhehEJWkbsVllGH9JSxcvYOm8lnNUO5CWnyD7lpmaW0-3DtwWw_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhq7VI4S3hk7SE0JtOUho7CsR-2BX3z7DHzABfh1jYkOvwTx4RnZbZSWXjj-2FLsdDinOoUGBD6L0DpherZv8ShL2qspzn7MUwvmTSOK-2BSjf3JkkFrH0EPXK-2BRdpbR9DfJ3SND9P3Xu-2BZPrXduSOghKzhhQQZ5a88kPMfuSkUN1rqiYQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C8a99e2b5c3194d70c3de08da8449105d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637967746581082538%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=X97B%2F5UiKTLxMyiIwXTGBSUVQGPifwqBXuX4qibS9CU%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbQne05VVe0UaW9iiRd6kqFruWj7MWNMTPouq26Q2yrp2g6dybslZayDlLfG5UOHJ-2Fw-3D-3DLXjF_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhq7VI4S3hk7SE0JtOUho7u5Xqsu8l7MtiRw1qXqWfSznS9vOXN4spFFHOAT8DcIH6W-2FTyDNw28ve4nsF8oG1lFH5nAsY-2F-2Fuio7my-2FlXLWGIqSkrawEyi9p0lXPuw0AyNO-2FTBB-2FiSfn-2FJom6YMDrVNogad8xUxp7SV-2F7STtTDu2g-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C8a99e2b5c3194d70c3de08da8449105d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637967746581082538%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=zHCSlvLl%2B7ZZslSUjISaLF32%2F7gTucPkvtAHtGLE7Ss%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: The results have been shared with the patients as they come for follow up for their standard clinical review with respect to their joint replacement surgery.
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbQne05VVe0UaW9iiRd6kqFruWj7MWNMTPouq26Q2yrp2g6dybslZayDlLfG5UOHJ-2Fw-3D-3DN9W6_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKhq7VI4S3hk7SE0JtOUho7si50W3Y-2Feg8lj03Js5PJw5SF317ktMT1cW-2FlZaTJZ0HYzGaBZoWrnkqEEJSUar-2F1nb8SFxxGzqFYbocyMIuh0kawZU3XBCg6urvXOw5cMZluueFBhUh-2FCTQojLn2U9XQir7jgoGZOXr2B7Yd5kl5yQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C8a99e2b5c3194d70c3de08da8449105d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637967746581082538%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8lBrNqgsn5kcYbpL2j0IW4tpaSBhOLRyd4vhZj2XQ4U%3D&reserved=0
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL: N/A - No tissue was sampled or tested.
  If no, explain why:
  Submitted on: 22/08/2022

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/1330

• Date of REC Opinion

  10 Nov 2014

• REC opinion

  Further Information Favourable Opinion