Status:
NOT_YET_RECRUITING
Robotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee Osteoarthritis
Lead Sponsor:
Satakunta Central Hospital
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age over 50 and below 80 years
- End-stage Kellgren-Lawrence grade IV KOA
- Failed conservative treatment
- Exclusion criteria
- Post-traumatic knee osteoarthritis
- Rheumatoid arthritis
- Previous knee infections
- Previous knee surgery (other than diagnostic arthroscopy or meniscectomy)
- Knee range of motion within 15 to 100 degrees
- Mechanical axis over 15 degrees of varus or over 10 degrees of valgus
- Body mass index over 40 kg/m2
- Significant patellofemoral osteoarthritis (Kellgren-Lawrence grade III or IV)
- Diabetes treated with insulin
- Malignancy with ongoing treatment
- Systemic glukocorticosteroid or antimetabolite medication during the last 5 years
- Conditions that do not allow general anesthesia
- Patients' denial for operative treatment and/or participation in the trial
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2037
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT07201207
Start Date
September 1 2025
End Date
September 1 2037
Last Update
October 1 2025
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