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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,…
