TEMA

• Research type

  Research Study

• Full title

  A post-market study evaluating clinical and radiographic outcomes of total elbow arthroplasty with TEMA.

• IRAS ID

  307881

• Contact name

  Adam Watts

• Contact email

  Adam.C.Watts@wwl.nhs.uk

• Sponsor organisation

  Lima Corporate S.p.A

• Clinicaltrials.gov Identifier

  NCT05180071

• Duration of Study in the UK

  7 years, 0 months, 1 days

• Research summary

  The TEMA elbow system is an innovative device intended to be used for total elbow replacement to reduce pain and give articular mobility to the patient. It has been developed to ensure the widest freedom of choice to the surgeon and to fit best the patient’s condition. It is CE marked and approved for use in the UK and in Europe.
  The purpose of this study is to obtain immediate, short, medium and long-term information about the safety and performance TEMA elbow system (replacement elbow joint device) and patient outcome measures over a 5 year period.
  The study will enrol 59 participants across up to 3 sites in UK and EU. The
  study will be carried out at one NHS site in England It is anticipated that recruitment will be completed within 2 years; all participants will be followed up for 5 years.

  Participants will attend a pre-operative visit before the device implant), intra-operative visit, (same day as device implant), discharge visit (after the device implant according to clinical practice), and follow-up visits at 6 weeks, 6 months and 1 year, 2 years, 3 years and 5 years after the implant.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0220

• Date of REC Opinion

  14 Nov 2022

• REC opinion

  Further Information Favourable Opinion