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

NCT ID: NCT07201207

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2037-09-30

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 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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Robotic-assisted total knee arthroplasty

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.

Group Type: EXPERIMENTAL

Robotic-assisted total knee arthroplasty

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Manual total knee arthroplasty

Intervention Type: PROCEDURE

In manual total knee arthroplasty, the procedure is performed with jig guides according to whole leg weight bearing x-ray planning.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Traditional total knee arthroplasty; Jig-guided total knee arthroplasty

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satakunta Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Juha Kukkonen

Docent, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silja Voutilainen, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Central Contacts

Juha Kukkonen, dos MD

Role: CONTACT

juha.kukkonen@sata.fi

+358 45 177 7747

Aleksi Annaniemi, PhD MD

Role: CONTACT

aleksi.annaniemi@sata.fi

+358 505117060

Other Identifiers

VARHA/28584/13.02.02/2024

Identifier Type: -

Identifier Source: org_study_id