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Mako Cementless TKA vs Mako Cemented TKA

Key facts

Who runs it
University College, London
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
120 people, planned
Started
29 Sept 2025
Expected to end
1 Aug 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Mako cementless TKA
  • Mako cemented TKA
Record updated
20 February 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Patient has symptomatic knee osteoarthritis requiring primary TKA
  • Patient and surgeon are in agreement that TKA is the most appropriate treatment
  • Patient is fit for surgical intervention following review by surgeon and anaesthetist
  • Patient is over 18 years old at time of surgery
  • Gender: male and female
  • Patient must be capable of giving informed consent and agree to comply with the postoperative review program
  • Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Who cannot take part

  • Patient is not medically fit for surgical intervention
  • Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
  • Patient is less than 18 years at time of surgery
  • Previous pathological fracture
  • Patient is immobile or has another neurological condition affecting musculoskeletal function
  • Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
  • Patient has bone loss that requires augmentation
  • Patient has a DEXA scan with T-score < -2.5 at any point
  • Patient is unable or unwilling to sign the informed consent form specific to this study
  • Patient is unable to attend the follow-up programme

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The overall aims of this prospective, randomised, single-blinded controlled trial are to compare functional, radiological and clinical outcomes in Mako robotic-arm assisted cementless Total Knee Arthroplasty (TKA) versus Mako robotic-arm assisted cemented TKA.

The 2 groups in the trial

  • Mako cementless TKATreatment being tested

    Mako robotic-arm assisted total knee arthroplasty using cementless implants

  • Mako cemented TKAExisting treatment, for comparison

    Mako robotic-arm assisted total knee arthroplasty using cemented implants

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective Randomised Controlled Trial Comparing Cementless Mako Robotic-arm Assisted Total Knee Arthroplasty Versus Cemented Mako Robotic-arm Assisted Total Knee Arthroplasty.
Record updated
20 February 2026
Under construction, not live – Mako Cementless TKA vs Mako Cemented TKA (NCT06929871) – Frontlight Research