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Robotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee Osteoarthritis

NCT07201207 · Satakunta Central Hospital · Updated 1 Oct 2025

What is being tested
Robotic-assisted total knee arthroplasty; Manual total knee arthroplasty
For
Osteoarthritis, Knee
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 50 years to 80 years. About 170 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started Sept 2025, ends Sept 2037. Registered 1 Oct 2025.
Results
None posted yet.

In the researchers' words

Background: Total knee arthroplasty is a golden standard procedure for end-stage knee osteoarthritis. However, up to 20% of the patients are not satisfied with the outcome. Recently, robotic-assisted TKAs have been developed to offer individual alignment and to achieve accuracy in positioning with more subtle soft-tissue handling, thus possibly leading into better outcome. Hypothesis: The investigators hypnotize that, robotic-assisted TKA is superior to manual TKA for end-stage osteoarthritis in respect to functional outcome, short-term rehabilitation and cost-efficiency. Trial desing: The investigators will conduct a single-center, randomized, controlled, double blinded superiority trial of 24-months to compare robotic-assisted and manual total knee arthroplasty in respect to functional outcome, implant positioning, short-term rehabilitation and cost-efficiency with up to 10 years follow-up for complications. The principle outcome measure will be patient reported outcome measure (PROM) Oxford knee score (OKS) points (0-48 points) at two years after surgery. Minimal clinically important difference will be considered as 5 points. Other PROMS, patient satisfaction, short-term rehabilitation, implant positioning, knee range of motion, length of sick leave and cost efficiency will also be reported. Patients will be followed up to 10 years for complications (infection,…
ClinicalTrials.gov, NCT07201207