Status:
NOT_YET_RECRUITING
Mako Cementless TKA vs Mako Cemented TKA
Lead Sponsor:
University College, London
Collaborating Sponsors:
Stryker Nordic
Conditions:
Total Knee Replacement
Total Knee Replacement Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Arthr...
Detailed Description
Osteoarthritis of the knee accounts approximately for 85% of the disease burden across the globe10. Almost one in six people is affected by knee arthritis and according to the latest National Joint Re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06929871
Start Date
July 1 2025
End Date
August 1 2031
Last Update
July 8 2025
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