Actively Recruiting
A Prospective Randomised Controlled Trial Comparing Cementless Mako Robotic-arm Assisted Total Knee Arthroplasty Versus Cemented Mako Robotic-arm Assisted Total Knee Arthroplasty
Led by University College, London · Updated on 2026-02-20
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
S
Stryker Nordic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of two types of total knee arthroplasty (TKA) in patients with symptomatic knee osteoarthritis. This prospective, randomized, single-blinded controlled trial compares functional, radiological, and clinical results of Mako robotic-arm assisted cementless TKA versus cemented TKA. The study aims to assess if cementless fixation offers superior benefits, considering the increasing number of younger patients undergoing TKA and concerns over implant loosening and patient satisfaction. Participants will receive Mako robotic-arm assisted total knee arthroplasty using either cementless or cemented implants. The robotic system uses preoperative CT scans to create a 3D model for precise bone resection and implant positioning. Patients are assigned to either the cementless or cemented TKA group, with surgery planned to optimize limb alignment and bone preservation. The trial is a superiority design aiming to determine if cementless TKA leads to better outcomes. During the study, participants will be followed for up to five years with various assessments including the Forgotten Joint Score at one year, radiostereometric analysis to measure implant migration, and clinical evaluations such as knee mobility, pain requirements, and quality of life questionnaires. Safety, complications, and healthcare costs will also be tracked. Follow-up visits will include radiographs and clinical reviews to monitor implant stability and function over time.
CONDITIONS
Brief Title
Mako Cementless TKA vs Mako Cemented TKA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has symptomatic knee osteoarthritis requiring primary total knee arthroplasty
- Patient and surgeon agree that total knee arthroplasty is the most appropriate treatment
- Patient is medically fit for surgery after review by surgeon and anaesthetist
- Patient is 18 years old or older at time of surgery
- Male or female gender
- Patient can give informed consent and agrees to follow postoperative review program
- Patient has enough mobility after surgery to attend follow-up clinics and allow radiographs
You will not qualify if you...
- Patient is unsuitable for routine primary total knee arthroplasty (e.g., needs constrained prosthesis due to ligament deficiency)
- Patient has bone loss requiring augmentation
- Patient is not medically fit for surgery
- Patient requires revision surgery after failed previous knee operations
- Patient has osteoporosis with DEXA scan T-score below -2.5
- Patient is immobile or has neurological condition affecting musculoskeletal function
- Patient is under 18 years old at time of surgery
- Patient is unable or unwilling to sign informed consent form for this study
- Patient is unable to attend follow-up visits
- Patient has previous pathological fracture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo Mako robotic-arm assisted total knee arthroplasty using either cementless or cemented implants.
1 visit (in-person surgery)
Duration - Up to 5 years
Participants are monitored to assess implant stability, clinical outcomes, and recovery through radiostereometric analysis and functional assessments.
Multiple visits at 1 week, 1 year, 2 years, and 5 years post-operation
Trial Site Locations
Total: 1 location
1
UCL Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
J
Jenni Tahmassebi, BSc MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here