RCT: Mako Cementless TKA vs Mako Cemented TKA

  • Research type

    Research Study

  • Full title

    A prospective randomised controlled trial comparing cementless Mako robotic-arm assisted total knee arthroplasty versus cemented Mako robotic-arm assisted total knee arthroplasty.



  • Contact name

    Fares Haddad

  • Contact email


  • Sponsor organisation

    University College London

  • Duration of Study in the UK

    7 years, 6 months, 1 days

  • Research summary

    One in five people in the UK suffers from knee arthritis and over 300,000 total knee replacement (TKR) procedures; an effective treatment for osteoarthritis; were undertaken in the UK in the last three years. However, younger patients have consistently shown poorer outcomes following TKRs. Furthermore, there is a relatively high incidence of patient dissatisfaction, with up to 20% of patients reporting dissatisfaction in an otherwise uncomplicated TKA. Accurate implant fixation in TKR is key to achieving the best outcomes. Implants can be stabilised with or without the use of cement and the optimal method is yet to be established.
    The study will include 120 patients with arthritis affecting the knee joint undergoing TKA at University College Hospital. Following informed consent, patients will be randomised into one of the two treatment groups and undergo Mako robotic-arm assisted TKA using cementless implants (Investigation group) or cemented implants (control group). In both groups a posterior stabilised knee system will be utilised. Clinical and functional progress will be recorded at regular intervals for two years after surgery. All patients will also undergo radiostereometric analysis (RSA) to assess implant stability and migration between the two treatment groups and blood tests to evaluate the inflammation incited. RSA involves the insertion of inert tantalum beads around the implants and serial radiographs to assess implant migration.
    Findings of this study will enable an improved understanding of the radiological, clinical and functional benefits of cementless fixation compared to cemented fixation in TKA. Research finding can be translated in real life and be used to improve outcomes in total knee arthroplasty; better patient functional outcomes and satisfaction; improved long-term implant survival; better outcomes for the exponentially growing number of younger patients pursuing TKA. Furthermore, our research will examine which procedure is more cost-effective, generating valuable financial data.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    21 Dec 2023

  • REC opinion

    Favourable Opinion