Robotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic-assisted total knee arthroplasty, Manual total knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Single-center, Randomized, Controlled, Double Blinded, 24-month Trial to Compare Robotic-assisted (MAKO) and Manual Total Knee Arthroplasty for Primary Osteoarthritis With 10 Year Follow-up for Complications
Overview
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, manipulation and revisions). This study will be conducted in Central Hospital of Satakunta (Satasairaala), Finland. The investigators will recruit 170 adult patients (aged 50-80), with end-stage (Kellgren-Lawrence grade IV) primary osteoarhritis. Patients will be randomly assingned to either robotic-assisted or manual TKA. Patients will be blinded by the intervention method used. Personnel and investigators assessing the patients and interpreting the data will also be blinded to the surgical method.
Interventions
- Device Robotic-assisted total knee arthroplasty
In robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan. - Procedure Manual total knee arthroplasty
In manual total knee arthroplasty, the procedure is performed with jig guides according to whole leg weight bearing x-ray planning.
Primary outcome measures
- Oxford Knee score OKS at 24 months [Time frame: 24 month]
Secondary outcome measures (12)
- Oxford Knee Score at 3 and 12 months [Time frame: 3 and 12 months visits]
- Knee injury and Osteoarthritis Outcome Score (KOOS) at 3, 12 and 24 months [Time frame: 3, 12 and 24 months]
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 12 and 24 months. [Time frame: 3, 12 and 24 months]
- Patient satisfaction inquiry at 3, 12 and 24 months [Time frame: 3, 12 and 24 months]
- Working ability, lenght of the sick leave [Time frame: up to 24 months]
- Working ability, part-time vs full-time [Time frame: Asked at 3 month, 12 months and 24 months after the surgery]
- Working ability, physical demands of the job [Time frame: Asked at 3 month, 12 months and 24 months after the surgery]
- Life quality questionnaire 15 dimensions (15D) at 3, 12 and 24 months [Time frame: 3, 12 and 24 months]
- Pain at rest and during walking on visual analoque scale (VAS) [Time frame: First day after the operation and at 3, 12 and 24 months]
- Opioid usage [Time frame: Up to two weeks]
- Blood loss [Time frame: First day after the operation]
- Lenght of the hospital stay [Time frame: Up to 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07201207 · VARHA/28584/13.02.02/2024