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NCT Number: NCT07201207

Robotic-assisted (MAKO) Versus Manual Total Knee Arthroplasty for Knee Osteoarthritis

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-assisted total knee arthroplasty

Device

In robotic-assisted total knee arthroplasty, the procedure is performed with the guidance of the robot according to CT-based plan.

Manual total knee arthroplasty

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Oxford Knee Score at 3 and 12 months

    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.

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) at 3, 12 and 24 months

    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).

  3. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 12 and 24 months.

    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.

  4. Patient satisfaction inquiry at 3, 12 and 24 months

    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.

  5. Working ability, lenght of the sick leave

    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.

  6. Working ability, part-time vs full-time

    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.

  7. Working ability, physical demands of the job

    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.

  8. Life quality questionnaire 15 dimensions (15D) at 3, 12 and 24 months

    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.

  9. 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

    pain at rest and during walking on visual analoque scale (VAS) from 0 (=no pain) to 10 (=extreme pain)

  10. Opioid usage

    Time frame: Up to two weeks

    Opioid usage mg/day

  11. Blood loss

    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.

  12. Lenght of the hospital stay

    Time frame: Up to 1 week

    Length of hospital stay measured in days.

  13. Operation time

    Time frame: Day of the surgery

    Time of the operation in hours and minutes checked form patient files.

  14. Post-operative CRP

    Time frame: First day after the operation

    post-op CRP as a indirect soft-tissue damage measure

  15. Knee swelling

    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

  16. Range of knee motion (ROM)

    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.

  17. Radiological outcome measures, alingment

    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.

  18. Radiological outcome measures, posterior condylar offset

    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

  19. Radiological outcome measures, Insall-salvati ratio

    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.

  20. Radiological outcome measures, Overhanging

    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.

  21. Radiological outcome measures, Notching

    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.

  22. Complications, revisons

    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

  23. Complications, infections

    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

  24. Complications, knee manipulation under anestesia due stiff knee

    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

  25. Complications, re-admission

    Time frame: up to 24 months

    Unplanned post-operative re-admissions due to the knee operation. Measured as days at the ward.

  26. Complications, unplannet emergency unit visits

    Time frame: up to 24 months

    Unplanned post-operative visits to the hospital emergency unit due to the knee operation, number of visits

  27. Costs

    Time frame: up to 24 months

    Total cost of the treatment, measured as amount of money.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksi Annaniemi, PhD MD

CONTACT

[email protected]

+358 505117060

Juha Kukkonen, dos MD

CONTACT

[email protected]

+358 45 177 7747

Sponsors and collaborators

Lead sponsor

Satakunta Central Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2037
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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