PERFORM+3 lateralised glenoid in OA and CTA

• Research type

  Research Study

• Full title

  Results after 2 years of reverse shoulder arthroplasty with a lateralised glenoid baseplate in patients presenting cuff tear arthropathy or primary osteoarthritis

• IRAS ID

  233149

• Contact name

  Lindsay Cunningham

• Contact email

  lindsay.j.cunningham@wwl.nhs.uk

• Sponsor organisation

  WWL NHS Foundation Trust

• Duration of Study in the UK

  1 years, 0 months, 16 days

• Research summary

  The study is being conducted to evaluate the performance and outcomes of the PerFORM+3 glenoid component as used as part of a total shoulder replacement. Approximately 45 patients have had this specific CE marked implant as part of routine care since January 2016 at this Trust, we aim to follow up patients within this cohort who are 2 years or more since the original arthroplasty operation. This type of shaped and lateralised implant allows badly damaged glenoid bone to still accommodate the components to allow a total shoulder replacement to be performed with the aim of restoring normal function.
  As the product is relatively new to the market and obtained CE certification based on substantial equivalence to similar open market products, we hope to evaluate the performance outcomes, safety and stability of this implant with a view to informing a wider audience of the efficacy of this specific implant and the principles of lateralising the glenoid component.
  Patients who have already reached 2 years since operation and have had clinical follow up will only be asked to complete outcome measure questionnaires to compare against pre-op scores. Patients who have not been seen for their 2 year check for various reasons (including those who have been discharged from this Trust to local care) are to be invited to a clinical visit where outcome measures, radiographs and range of movement measurements will be obtained. All radiographs from all consented patients will be reviewed for signs of radio-lucent lines (signs of loosening around the glenoid component) and integration of the metal component to the shoulder native bone. All obtained outcome measures and clinical observations will be compared to pre-operative scores and descriptive statistics used to describe overall change within the group to establish if there has been a favourable outcome.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  19/NW/0748

• Date of REC Opinion

  14 Feb 2020

• REC opinion

  Further Information Favourable Opinion