Osteoarthritis, KneeNCT07201207
Robotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee Osteoarthritis
A study testing Robotic-assisted total knee arthroplasty and Manual total knee arthroplasty in people with Osteoarthritis, Knee, run by Satakunta Central Hospital.
Trial 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 TKAs have been developed to offer individual alignment and to achieve accuracy in positioning with more subtle… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Robotic-assisted total knee arthroplasty and Manual total knee arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50 and below 80 years
- End-stage Kellgren-Lawrence grade IV KOA
- Failed conservative treatment
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Robotic-assisted total knee arthroplasty, Manual total knee arthroplasty
- Keywords
- arthroplasty, robotic-assisted arthroplasty, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted total knee arthroplastyDevice
In robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan.
Manual total knee arthroplastyProcedure or surgery
Also called Traditional total knee arthroplasty, Jig-guided total knee arthroplasty
In manual total knee arthroplasty, the procedure is performed with jig guides according to whole leg weight bearing x-ray planning.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted total knee arthroplasty | Experimental | The intervention group will undergo MAKO assisted RATKA. The patients will have individualized alignment. Knee balance is achieved with bony cuts and implant positioning, to avoid soft tissue releases. A preoperative planning based on computed tomography (CT) scans is made and intraoperatively computer assisted gap balancing is performed based on the plan and patient's soft tissue envelope and native joint line. The precise pre-operative planning, balancing and alignment method has been described by Calliess T el al. Receives: Device: Robotic-assisted total knee arthroplasty |
| Manual total knee arthroplasty | Active comparator | The control group will undergo manual jig-guided TKA, with bony cuts made to achieve neutral mechanical axis, and if necessary, knee balancing will be performed by soft tissue releases. Weight bearing semi-flexion radiographs and long leg radiographs are used for preoperative planning. Intramedullary guiding rod is used in femur to align the cuts in 6 to 7 degrees of valgus. Femoral component rotation is fixed to trans-epicondylar line. Tibia cuts are aligned with either intra- or extramedullary guiding rod according to the preference of the surgeon. Tibia component rotation is fixed to medial one-third of tibial tubercle. After bony cuts, knee balancing is performed with soft-tissue and ligament releases if necessary. Receives: Procedure: Manual total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee score OKS at 24 months
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.
Measured: 24 month
Secondary outcomes (27)
Oxford Knee Score at 3 and 12 months
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.
Measured: 3 and 12 months visits
Knee injury and Osteoarthritis Outcome Score (KOOS) at 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).
Measured: 3, 12 and 24 months
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 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.
Measured: 3, 12 and 24 months
Patient satisfaction inquiry at 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.
Measured: 3, 12 and 24 months
Working ability, lenght of the sick leave
Length of the sick leave after the surgery, measured as days. Asked from the patient and checked from the patient files.
Measured: up to 24 months
Working ability, part-time vs full-time
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.
Measured: Asked at 3 month, 12 months and 24 months after the surgery
Working ability, physical demands of the job
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.
Measured: Asked at 3 month, 12 months and 24 months after the surgery
Life quality questionnaire 15 dimensions (15D) at 3, 12 and 24 months
Life quality questionnaire 15 dimensions at 3 follow up visits. Scale from 15 (=exellent) to 75 (=worst) points.
Measured: 3, 12 and 24 months
Pain at rest and during walking on visual analoque scale (VAS)
pain at rest and during walking on visual analoque scale (VAS) from 0 (=no pain) to 10 (=extreme pain)
Measured: First day after the operation and at 3, 12 and 24 months
Opioid usage
Opioid usage mg/day
Measured: Up to two weeks
Blood loss
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.
Measured: First day after the operation
Lenght of the hospital stay
Length of hospital stay measured in days.
Measured: Up to 1 week
Operation time
Time of the operation in hours and minutes checked form patient files.
Measured: Day of the surgery
Post-operative CRP
post-op CRP as a indirect soft-tissue damage measure
Measured: First day after the operation
Knee swelling
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
Measured: First day after the operation
Range of knee motion (ROM)
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.
Measured: First day after the operation and at 3, 12 and 24 months visits
Radiological outcome measures, alingment
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.
Measured: Weight bearing whole leg x-rays taken 3 months post-operatively.
Radiological outcome measures, posterior condylar offset
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
Measured: post-operative knee x-rays taken within 1 week after the operation
Radiological outcome measures, Insall-salvati ratio
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.
Measured: post-operative knee x-rays taken within 1 week after the operation
Radiological outcome measures, Overhanging
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.
Measured: post-operative knee x-rays taken within 1 week after the operation
Radiological outcome measures, Notching
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.
Measured: post-operative knee x-rays taken within 1 week after the operation
Complications, revisons
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
Measured: 3, 12 and 24 months and five and ten years
Complications, infections
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
Measured: 3, 12 and 24 months and five and ten years after surgery
Complications, knee manipulation under anestesia due stiff knee
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
Measured: 3, 12 and 24 months and five and ten years after surgery.
Complications, re-admission
Unplanned post-operative re-admissions due to the knee operation. Measured as days at the ward.
Measured: up to 24 months
Complications, unplannet emergency unit visits
Unplanned post-operative visits to the hospital emergency unit due to the knee operation, number of visits
Measured: up to 24 months
Costs
Total cost of the treatment, measured as amount of money.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionSep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satakunta Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juha Kukkonen, Satakunta Central Hospital
- Investigators
- Silja Voutilainen, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201207
- Sponsor's protocol ID
- VARHA/28584/13.02.02/2024
- Status last verified
- May 2025
- First submitted
- 28 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07201207
- Acronym / sponsor ID
- VARHA/28584/13.02.02/2024
- Conditions
- Osteoarthritis, Knee
- Keywords
- arthroplasty, robotic-assisted arthroplasty, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Satakunta Central HospitalUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2037 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted total knee arthroplasty | Experimental | Device: Robotic-assisted total knee arthroplastyThe intervention group will undergo MAKO assisted RATKA. The patients will have individualized alignment. Knee balance is achieved with bony cuts and implant positioning, to avoid soft tissue releases. A preoperative planning based on computed tomography (CT) scans is made and intraoperatively computer assisted gap balancing is performed based on the plan and patient's soft tissue envelope and native joint line. The precise pre-operative planning, balancing and alignment method has been described by Calliess T el al. |
| Manual total knee arthroplasty | Active comparator | Procedure: Manual total knee arthroplastyThe control group will undergo manual jig-guided TKA, with bony cuts made to achieve neutral mechanical axis, and if necessary, knee balancing will be performed by soft tissue releases. Weight bearing semi-flexion radiographs and long leg radiographs are used for preoperative planning. Intramedullary guiding rod is used in femur to align the cuts in 6 to 7 degrees of valgus. Femoral component rotation is fixed to trans-epicondylar line. Tibia cuts are aligned with either intra- or extramedullary guiding rod according to the preference of the surgeon. Tibia component rotation is fixed to medial one-third of tibial tubercle. After bony cuts, knee balancing is performed with soft-tissue and ligament releases if necessary. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 50 and below 80 years
- End-stage Kellgren-Lawrence grade IV KOA
- Failed conservative treatment
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted total knee arthroplastyIn robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan. | Device | Robotic-assisted total knee arthroplasty |
| Manual total knee arthroplastyAlso: Traditional total knee arthroplasty, Jig-guided total knee arthroplastyIn manual total knee arthroplasty, the procedure is performed with jig guides according to whole leg weight bearing x-ray planning. | Procedure or surgery | Manual total knee arthroplasty |
Primary outcome
Oxford Knee score OKS at 24 months
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.
27 secondary outcomes
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
Operation time
Time frame: Day of the surgery
Post-operative CRP
Time frame: First day after the operation
Knee swelling
Time frame: First day after the operation
Range of knee motion (ROM)
Time frame: First day after the operation and at 3, 12 and 24 months visits
Radiological outcome measures, alingment
Time frame: Weight bearing whole leg x-rays taken 3 months post-operatively.
Radiological outcome measures, posterior condylar offset
Time frame: post-operative knee x-rays taken within 1 week after the operation
Radiological outcome measures, Insall-salvati ratio
Time frame: post-operative knee x-rays taken within 1 week after the operation
Radiological outcome measures, Overhanging
Time frame: post-operative knee x-rays taken within 1 week after the operation
Radiological outcome measures, Notching
Time frame: post-operative knee x-rays taken within 1 week after the operation
Complications, revisons
Time frame: 3, 12 and 24 months and five and ten years
Complications, infections
Time frame: 3, 12 and 24 months and five and ten years after surgery
Complications, knee manipulation under anestesia due stiff knee
Time frame: 3, 12 and 24 months and five and ten years after surgery.
Complications, re-admission
Time frame: up to 24 months
Complications, unplannet emergency unit visits
Time frame: up to 24 months
Costs
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silja Voutilainen, MD, PhD study chair
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted total knee arthroplasty and Manual total knee arthroplasty in people with Osteoarthritis, Knee, run by Satakunta Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juha Kukkonen, dos MD (+358 45 177 7747, juha.kukkonen@sata.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Knee score OKS at 24 months (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.