Status:
COMPLETED
Mako Functionally Aligned Total Knee Arthroplasty vs Mako Mechanically Aligned Total Knee Arthroplasty
Lead Sponsor:
University College, London
Collaborating Sponsors:
Stryker Orthopaedics
Conditions:
Osteo Arthritis Knee
Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty \[MA TKA\] versus robotic-arm assisted functionally aligned total knee arthroplasty \[FA TKA\]. Half ...
Detailed Description
Total knee arthroplasty \[TKA\] is an estabilshed treatment for symptomatic end-stage knee osteoarthritis, but there is a higher disatisfaction rate when compared to total hip arthroplasty. The exact ...
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 between 18-80 years of age 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 be a permanent resident in an area accessible to the study site
- 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 is immobile or has another neurological condition affecting musculoskeletal function
- Patient is less than 18 years of age or greater than 80 years of age
- Patient is already enrolled on another concurrent clinical trial
- Patient is unable or unwilling to sign the informed consent form specific to this study
- Patient is unable to attend the follow-up programme
- Patient is non-resident in local area or expected to leave the catchment area postoperatively
Key Trial Info
Start Date :
December 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04092153
Start Date
December 28 2018
End Date
February 6 2025
Last Update
July 9 2025
Active Locations (1)
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1
University College London Hospital NHS Foundation Trust
London, United Kingdom, NW1 2PG