Mako Cementless TKA vs Mako Cemented TKA
Recruiting · NCT06929871 · Interventional (participants receive a specific treatment) · Lead sponsor: University College, London
View the official record on ClinicalTrials.gov →Interventions studied
Mako cemented TKAMako cementless TKA
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- UCL Hospitals NHS Foundation Trust - London, United Kingdom