Robotic Assisted Surgery In Total Knee Replacement

Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial

The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement.

The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score.

Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Triathlon

Detailed Description

Study Title:

Robotic Assisted Surgery in total knee replacement versus Manual Total Knee Arthroplasty: A randomised controlled trial

Type of study:

CE marked device study

Trial Design:

Multi-center site prospective parallel group randomised controlled trial

Trial Participants:

Listed for routine primary total knee replacements

Investigational Device:

MAKO Robotic Arm Assisted Surgical System

Control:

Conventional jig-based surgery

Implant (Intervention and Control):

Triathlon TKR

Planned Sample Size:

200 (100 MAKO, 100 Manual)

Follow-up duration:

24 months following surgery

Planned Trial Period:

Nov 2022 - 2024

Primary Objective:

To compare changes in joint awareness (measured by the Forgotten Joint Score (FJS)20) from baseline to 12 months following TKR between the two groups.

Secondary Objectives

1. To compare pain measured using the pain visual analogue scale.
2. To compare the health-related quality of life using the EQ5D-3L at baseline, 3, 12 and 24 months.
3. To compare changes in knee function in activities of daily living (measured by the Oxford knee score (OKS)19) from baseline to 3, 12 and 24 months.
4. To compare changes in clinically assessed pain and stiffness (measured by the Knee Society Score (KSS)) at baseline to 3 and 12 months.
5. To compare revision rate using implant migration measured by CTMA at 12 and 24 months as a surrogate marker for revision.

Primary Endpoint:

Functional outcome measured by the changes in joint awareness of the FJS score at 12 months following the intervention.

Secondary Endpoints:

Secondary outcomes will be collected up to 24 months following the intervention.

Device Name:

Both arms will receive Triathlon TKR with a highly crossed linked (X3) cruciate retaining polyethylene insert.

The intervention group will utilise the MAKO robotic arm to make the bone cuts.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Maziar Mohaddes, Associate Professor, MD; Phone Number: 0046313421000; Email: mazmo1@vgregion.se
    • Principal Investigator: Mazaíar Mohaddes, Assoc Professor, MD
  • Örebro, Sweden, 705 85
    • Recruiting
    • Örebro University Hospital, Department of Medical Sciences
    • Contact: Per Wretenberg, Professor; Phone Number: 0046706636686; Email: per.wretenberg@regionorebrolan.se
    • Contact: Gunnar Falk, MD; Phone Number: 004670-5698284; Email: gunnar.falk@regionorebrolan.se
    • Principal Investigator: Per Wretenberg, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Listed for elective primary TKR for end stage osteoarthritis
• Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)
• Male or Female, aged 18 years or above (18-80 at the time of listing for surgery).
• Able to understand and provide written consent.

Exclusion Criteria:

• Varus deformity of > 20 degrees observed by consultant on examination
• Patient is unable to comply with the study protocol (incl. refusal for CT scan)
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
• Requires patella resurfacing
• Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional	Device: Triathlon; Total knee arthroplasty
Experimental: MAKO TKA	Device: Triathlon; Total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forgotten Joint Score	Patient-reported outcome	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee pain	Patient-reported outcome	2 years
EQ-5D	Patient-reported outcome	3, 12, 24 months
Oxford Knee Score	Patient-reported outcome	3, 12, 24 months
Knee Society Score	Physician-reported outcome	3, 12, 24 months

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Stryker Nordic

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RAKER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No