Robotic-assisted total knee arthroplasty
DeviceIn robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan.
NCT Number: NCT07201207
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.
Trial opening soon.
Get Notified50 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan.
In manual total knee arthroplasty, the procedure is performed with jig guides according to whole leg weight bearing x-ray planning.
Other names: Traditional total knee arthroplasty, Jig-guided total knee arthroplasty
Time frame: 24 month
Patient reported outcome measure, knee function questionnaire Oxford Knee Score (OKS) at 24 month. Scale from 0 (=worst) to 48 (=excellent) points Minimal clinically important difference considered as 5 points.
Time frame: 3 and 12 months visits
Patient reported outcome measure, knee function questionnaire Oxford Knee Score (OKS) at 3 and 12 months. Scale from 0 (=worst) to 48 (=excellent) points. Minimal clinically important difference considered as 5 points.
Time frame: 3, 12 and 24 months
Patient reported outcome measure, knee function questionnaire KOOS points at 3, 12 and 24 months after the operation. Scale from 0 (=worst) to 100 (=excellent).
Time frame: 3, 12 and 24 months
Patient reported outcome measure, knee function questionnaire WOMAC score at 3, 12 and 24 months after the operation. Scale from 0 (= excellent) to 96 (= worst) points.
Time frame: 3, 12 and 24 months
Patient satisfaction question asked at 3, 12 and 24 months after the operation: If you could choose again, would you still go for the sugery? 0= no 1 = probably not 2= I don't know 4 = probably yes 5 = yes.
Time frame: up to 24 months
Length of the sick leave after the surgery, measured as days. Asked from the patient and checked from the patient files.
Time frame: Asked at 3 month, 12 months and 24 months after the surgery
Asked from the patient at the 3, 12 and 24 months follow-ups visits. Has the operation changed your ability to work full-time or part-time? Options: a) yes my work changed from full-time to part-time after surgery b) no my work is as much full-time or part-time as it was before the surgey c) yes my work changed from full-time to part-time after surgery d) my work as part-time or full-time has changed from other reasons not related to the knee.
Time frame: Asked at 3 month, 12 months and 24 months after the surgery
Asked from the patient at the 3, 12 and 24 months follow-ups visits. Has the physical demands of your job changed after the operation because of the knee? Options: a) yes the physical demands of my job is now lower than it was before the surgery b) no my work is as physically demanding as it was before the surgery c) yes the physical demands of my job is now higher than it was before the surgery d) the physical demands of my job has changed from other reasons not related to the knee.
Time frame: 3, 12 and 24 months
Life quality questionnaire 15 dimensions at 3 follow up visits. Scale from 15 (=exellent) to 75 (=worst) points.
Time frame: First day after the operation and at 3, 12 and 24 months
pain at rest and during walking on visual analoque scale (VAS) from 0 (=no pain) to 10 (=extreme pain)
Time frame: Up to two weeks
Opioid usage mg/day
Time frame: First day after the operation
Blood loss evaluated by the by measuring pre- and post-operative (first day after surgery) hemoglobin g/L. Difference between the pre-operative and post-operative Hemoglobin (g/L) values.
Time frame: Up to 1 week
Length of hospital stay measured in days.
Time frame: Day of the surgery
Time of the operation in hours and minutes checked form patient files.
Time frame: First day after the operation
post-op CRP as a indirect soft-tissue damage measure
Time frame: First day after the operation
Knee swelling, knee diameter measured above the patella and compared to the unaffected size, the diameter difference in centimeters between the legs. Indirect soft-tissue damage measures
Time frame: First day after the operation and at 3, 12 and 24 months visits
Range of knee motion measured with goniometry as degrees at the ward on first post-operative day and ant the 3, 12 and 24 months visits.
Time frame: Weight bearing whole leg x-rays taken 3 months post-operatively.
Knee alignment measured from post-operative weight bearing whole leg x-rays as degrees. Measured as the degrees between femoral mechanical axis line and tibial mechanical axis line.
Time frame: post-operative knee x-rays taken within 1 week after the operation
Post-op knee x-ray taken at the first post-operative day; posterior condylar offset, measured as maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex, measured in millimeters
Time frame: post-operative knee x-rays taken within 1 week after the operation
Measured from post-operative knee x-rays. Insall-salvati ratio: the length of the patellar tendon in millimeters divided by the length of the patella in millimeters.
Time frame: post-operative knee x-rays taken within 1 week after the operation
Measured from post-operative knee x-rays. Overhanging of the tibial or femoral component from medial lateral, posterior or anterior side measured as millimeters. The length between the bony edge to the edge of the component.
Time frame: post-operative knee x-rays taken within 1 week after the operation
Measured from post-operative knee x-rays. Notching of the anterior femoral cortex. The lenght in millimeters between the anterior femoral cortex and the anterior edge femoral component in sagittal x-ray.
Time frame: 3, 12 and 24 months and five and ten years
Revisions meaning re-operation of the knee due any reason. Checked from the patient files at 3, 12 and 24 months and five and ten years after surgery. Measured as number of revisions
Time frame: 3, 12 and 24 months and five and ten years after surgery
Infections that recuire antibiotics or revision surgery. Checked from the patient files at 3, 12 and 24 months and five and ten years after surgery. Measured as number of infections
Time frame: 3, 12 and 24 months and five and ten years after surgery.
Need for knee manipulations under anesthesia due stiff knee. Measured as number of manipulations. Checked form the patient files at 3, 12 and 24 months and five and ten years after surgery
Time frame: up to 24 months
Unplanned post-operative re-admissions due to the knee operation. Measured as days at the ward.
Time frame: up to 24 months
Unplanned post-operative visits to the hospital emergency unit due to the knee operation, number of visits
Time frame: up to 24 months
Total cost of the treatment, measured as amount of money.
Contact information is provided by the study sponsor or research team.
Aleksi Annaniemi, PhD MD
CONTACT
Juha Kukkonen, dos MD
CONTACT
Satakunta Central Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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