Metaphyseal Cones versus a Cemented Stem in Revision TKR V1.

• Research type

  Research Study

• Full title

  Proposal for A Prospective, Randomised Internal Pilot Study Investigating the Use of Metaphyseal Cones versus a Cemented Stem Construct in Revision Total Knee Replacement in Patients with AORI Grade 2 Defects- a Comparison of Clinical, Functional and Radiological Outcome.

• IRAS ID

  215815

• Contact name

  Alison Kerridge

• Contact email

  alison.kerridge@nhs.net

• Sponsor organisation

  RD+E Hospital

• Clinicaltrials.gov Identifier

  NCT03169634

• Duration of Study in the UK

  7 years, 0 months, 1 days

• Research summary

  In time, some total knee replacements (TKR) will fail-usually either because of wear or loosening of the replacement parts. Further, more complex surgery may be needed- revision TKR. When the old TKR is removed, a large cavity can be left in the bone. The new TKR has to be placed into this. The cavity has to be somehow either filled in or bypassed to ensure the new TKR is secure enough for early weight-bearing and long term survival.
  It may be possible to simply cement another TKR into the cavity -using short or long stemmed components. Alternatively, a device called a “cone” is placed into the bony cavity and a new TKR- with short or long stemmed components- can be cemented into this. Bone grows onto the cone to ensure its stability. All of these types of revision TKR are presently in use - no-one knows which type is best.
  We are trying to establish which type of revision TKR is best for patients. However, we need to do a pilot study as a rehearsal of all the procedures and logistics that will be undertaken in what is planned to be a full randomised study. We will look at questionnaires to measure how well the patients feel their knee is performing, specific tests to measure knee function, and use x-rays and scans to analyse the performance of the new TKR. The pilot study results will allow us to assess practical matters such recruitment and data collection issues and to calculate the sample size and study power for the substantive study.
  Patients who meet the inclusion criteria and consent to be in the study will be randomly allocated to receive one of the revision TKR options as outlined above and their progress monitored for 5 years after the operation.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  17/NW/0301

• Date of REC Opinion

  12 May 2017

• REC opinion

  Favourable Opinion