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

NCT07201207 | Not Yet Recruiting FDA Device

• 1 other identifier: VARHA/28584/13.02.02/2024
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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

Keywords

arthroplasty; robotic-assisted arthroplasty; knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  24 month

Secondary Outcomes (27)

• Oxford Knee Score at 3 and 12 months

  3 and 12 months visits

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

  3, 12 and 24 months

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

  3, 12 and 24 months

• Patient satisfaction inquiry at 3, 12 and 24 months

  3, 12 and 24 months

• Working ability, lenght of the sick leave

  up to 24 months

Study Arms (2)

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.

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.

Procedure: Manual total knee arthroplasty

Interventions

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.

Robotic-assisted total knee arthroplasty

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.

Also known as: Traditional total knee arthroplasty, Jig-guided total knee arthroplasty

Manual total knee arthroplasty

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 50 and below 80 years
• End-stage Kellgren-Lawrence grade IV KOA
• Failed conservative treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Satakunta Central Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Silja Voutilainen, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

Central Study Contacts

Juha Kukkonen, dos MD

CONTACT

+358 45 177 7747; juha.kukkonen@sata.fi

Aleksi Annaniemi, PhD MD

CONTACT

+358 505117060; aleksi.annaniemi@sata.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent, MD

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: October 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2037
• Last Updated: October 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share