RecruitingNot ApplicableNCT06929871

Mako Cementless TKA vs Mako Cemented TKA

A Prospective Randomised Controlled Trial Comparing Cementless Mako Robotic-arm Assisted Total Knee Arthroplasty Versus Cemented Mako Robotic-arm Assisted Total Knee Arthroplasty.

Sponsor

University College, London

Enrollment

120 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

Total Knee Replacement

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria10

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 is not medically fit for surgical intervention
Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
Patient has a DEXA scan with T-score \< -2.5 at any point
Patient is immobile or has another neurological condition affecting musculoskeletal function
Patient is less than 18 years at time of surgery
Patient is unable or unwilling to sign the informed consent form specific to this study
Patient is unable to attend the follow-up programme
Previous pathological fracture

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